Clinical Evaluation Report

For
DeVilbiss
5 Liter Oxygen Concentrator (model 525) with
accessories
and
iGo Portable Oxygen Concentrator (model 306) with
accessories

Version 1.0
28 August 2015

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Signature

Print Name Allan Jones

Date of Signature

Project Role Director of Engineering, DeVilbiss Healthcare

I have read and evaluated this CER and conclude with its findings:

Signature

Print Name Malgorzata Kaczorowska MD PhD

Date of Signature

Project Role Clinical Evaluator

The effective date is the date of the last signature.

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TABLE OF CONTENTS

Executive statement ............................................................................................................................. 6

1. General details ............................................................................................................. 8
2. Description of the Device and its Intended Application and Indications for Use . 9
2.1 5 Liter Oxygen Concentrator (base model 525) ............................................................ 9
2.2 iGo Portable Oxygen Concentrator (base model 306) ................................................ 11
3. Intended Therapeutic and/or Diagnostic Indications and Claims ........................ 14
3.1 Intended Therapeutic and/or Diagnostic Indications ................................................... 14
3.1.1 Supplemental oxygen therapy .............................................................................. 14
3.1.2 Patient groups requiring supplemental oxygen therapy ....................................... 14
3.1.3 LTOT delivery from oxygen concentrators ........................................................... 15
3.1.4 Guidelines for home oxygen use in adults .............................................................. 16
3.1.5 Paediatric use of oxygen concentrators ............................................................... 18
3.2 Safety and/or Performance Claims ............................................................................. 18
4. Context of the Evaluation and Choice of Clinical Data Types .............................. 19
4.1 Developmental Context ............................................................................................... 19
4.2 Justification of Clinical Data Type ............................................................................... 19
4.3 Justification of Equivalent Devices ....................................................................................... 20
5. Summary of the Clinical Data and Appraisal .......................................................... 28
6. Data Analysis ............................................................................................................. 29
6.1 Description of analysed data used to assess the device safety .................................. 29
6.1.1 Literature review ................................................................................................... 29
6.1.2 Post-market surveillance data (DeVilbiss)............................................................ 30
6.1.3 Post-market surveillance data (equivalent devices) ............................................. 30
6.2 Description of analysed data used to assess the device performance ................................ 31
6.2.1 Literature review ...................................................................................................... 31
6.3 Product Literature and Instructions for Use .......................................................................... 32
7. Post Market Surveillance and Clinical Follow-Up .................................................. 34
8. Conclusions ............................................................................................................... 36
Appendix A: Literature Review Report .......................................................................................... 37
Appendix B: Search of keywords ................................................................................................... 38
Appendix C: 1st level of selection: excluded articles .................................................................. 39
Appendix D: 2nd level of selection: included and excluded articles ......................................... 52
Appendix E: Criteria of suitability and Oxford level of evidence ................................................ 67
Appendix F: Search of clinical trial register (ie. Clinicaltrials.gov, WHO…) ............................. 69
Appendix G: Complaint/ Incidence Report .................................................................................... 70
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Appendix H: IFU document number or IFU ................................................................................... 97

Appendix I: Risk Analysis Report number or Risk Files ............................................................ 99
Appendix J: Justification of the choice of the evaluator(s) (ie. curriculum vitae / biographical
sketch of medical writer and clinical reviewer) .................................................... 100
8.1.1 Institute of Hearing Physiology and Pathology, Warsaw, Poland ...................... 108
8.1.2 Member of Polish Association of Otolaryngologists/Head & Neck Surgeons .... 114
Appendix K: Clinical Investigation Documents .......................................................................... 116
Appendix L: Regulatory References ............................................................................................ 117
Appendix M: References................................................................................................................ 118

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Executive statement
DeVilbiss is currently marketing two types of oxygen concentrators - the stationary 5 L Oxygen
Concentrator (model 525) and the portable iGo Oxygen Concentrator (model 306) – to provide
supplementary low flow oxygen therapy for patients suffering from chronic obstructive pulmonary
disease (COPD), cardiovascular disease, and lung disorders. Both are class IIa devices in
accordance with Annex II of 93/42/EEC, as amended by Directive 2007/47/EC.
The DeVilbiss Oxygen Concentrators models 525 and 306 have been in production since 2008 and
2009, respectively. These devices are produced to well-known designs. The clinical safety and
performance of DeVilbiss oxygen concentrators were therefore evaluated based on: compliance with
recognized standards; a literature review; and post-market surveillance data. Data on equivalent
devices was included in the clinical evaluation.
This clinical evaluation has shown that both models 525 and 306 are acceptable for safety and
performance if used according to their respective Instruction Guides. Both devices incorporate a full
range of desirable safety features. The Instruction Guides for models 525 and 306 reflect current best
use practices and inform clinicians and patients of potential problems and hazards associated with the
improper use of these devices.
The articles retrieved in the literature search performed for this clinical evaluation suggest further
improvements to the way assessments of portable pulse delivery devices (such as DeVilbiss iGo
Oxygen Concentrator model 306) are made by clinicians.
Between 1 January 2010 and 19 June 2015 customer complaints were made to DeVilbiss at a rate of
3.4% and 9.3% for models 525 and 306, respectively. Significantly, no adverse events or other patient
effects were noted in the complaints. Search of the FDA’s MAUDE database over the same period of
time for reports of incidents associated with equivalent devices (Respironics EverFlo and Respironics
EverGo) identified reports of patient deaths and injuries for the EverFlo device only. Smoking while
using the device was a factor in some deaths and injuries (a warning about this appears in the
Instruction Guide for the DeVilbiss 5L Oxygen Concentrator), but for most incidents a causative link to
the device could not be definitively established.
It is concluded that the clinical evidence appraised in this CER demonstrates conformity with the
relevant Essential Requirements of the MDD. The performance and safety of the devices as claimed
have been established. The devices are manufactured in such a way that when used under the
conditions and for the purposes intended, they will not compromise the clinical condition or the health
and safety of the user. The risks associated with the use of these devices are acceptable when
weighed against benefits to patients with chronic hypoxaemia requiring long term oxygen therapy.
No new hazards or complications related to DeVilbiss Oxygen Concentrators (models 525 and 306)
were identified in this Clinical Evaluation Report. Therefore, DeVilbiss does not believe post-market
clinical follow-up is required to support the safety and performance of these devices for their stated
indications. The need for additional post-market clinical follow-up will continue to be evaluated as part
of the clinical evaluation process during post-market surveillance activities in accordance with
MEDDEV 2.12.2 Rev. 2.

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Abbreviations
ABG Arterial blood gas
BTS British Thoracic Society
CBG Capillary blood gas
COPD Chronic obstructive pulmonary disease
CPAP Continuous positive airway pressure
FiO2 Fraction of inspired oxygen
LTOT Long term oxygen therapy
PaO2 Arterial oxygen tension (partial pressure)
PO2 Oxygen tension (partial pressure) in blood or alveolus
SpO2 Arterial oxygen saturation measured by pulse oximetry
SaO2 Arterial oxygen saturation measured by blood analysis (blood gases)
6MWT 6 minute walk test

Partial pressure units of measurement and conversion between them:

• Partial pressures of oxygen and carbon dioxide are measured using kilopascals (kPa) and
millimetres of mercury (mm Hg) where:
• 1 kPa=7.5 mm Hg, and 1 mm Hg=0.133 kPa. Details

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1. General details
This clinical evaluation report (CER) pertains to two oxygen concentrators manufactured by DeVilbiss
Healthcare (Somerset, PA, USA) – 5 Liter Oxygen Concentrator (model 525) and iGo Portable
Oxygen Concentrator (model 306).
This CER is written in accordance with directives MEDDEV 2.7.1 Rev. 3 and MEDDEV 2.12.2 Rev. 2
to provide evidence of the medical safety and performance of DeVilbiss oxygen concentrators for their
intended use.
DeVilbiss’ oxygen concentrators are devices that produce an oxygen enriched gas mixture by drawing
in ambient air and extracting nitrogen allowing oxygen to be delivered at a range of prescribed flows
to patients with low blood oxygen saturation levels. The patient typically receives the oxygen through
a nasal cannula. The oxygen concentrators are supplied with accessory devices.
DeVilbiss’ oxygen concentrators (models 525 and 306) are class IIa devices in accordance with
Annex II of 93/42/EEC, as amended by Directive 2007/47/EC.
The 5 Liter Oxygen Concentrator (model 525) was first released on the US market in February 2008.
It was released in the EU market April of 2008. The iGo Oxygen Concentrator (model 306) was
released on the US market and the EU market in January 2009.

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2. Description of the Device and its Intended Application and

Indications for Use
2.1 5 Liter Oxygen Concentrator (base model 525)
Description of device
The DeVilbiss 5 Liter Oxygen Concentrator (base model 525) is a 0.5 to 5.0 liter per minute (L/MIN)
continuous flow pressure swing adsorption (PSA) type system that produces oxygen.
The 5 Liter Oxygen Concentrator consists of pneumatic and electrical components. The system has
inlet filtration, air compressor, and synthetic zeolite molecular sieve beds with a pneumatic valve,
outlet filtration, electronic flow measuring, manual thorpe tube flowmeter and audible/visual alarms.

Figure 1: 5 Liter Oxygen Concentrator with a humidifier attached

Operating principle
The DeVilbiss 5 Liter Oxygen Concentrator is based on molecular sieve technology. The technology
employed to generate the oxygen is well established.
Room air is drawn into the concentrator via a piston style compressor. The air then passes through a
series of filters that remove dust, bacteria, and other particulates. A pneumatic valve directs air into
one of the two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases while oxygen
flows through, thereby producing an enriched oxygen product for the patient. Simultaneously in the
other bed, nitrogen is desorbed as the pressure decreases and is exhausted into the atmosphere. A
momentary intermediate pneumatic sequence ties the beds together with the exhaust blocked for an
enhanced oxygen purge. The cycle continues, providing a continuous flow of oxygen at a purity of
93% +/-3% to the patient.

Components
The base model 525 Series includes the following parts:

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Catalogue # Item
1 2 2
525DS / 525KS / 525PS Oxygen Concentrator, AC power cord

525DZ-609 Gross particle filter

MC44D-605 Intake Filter

SE-525 Instruction guide

1
NO CE MARK
2
CE Marked

Specifications:

Dimension (H x W x D) 62.2 x 34.2 x 30.4 cm

Weight 16.3 kg

Flow rate 0.5 to 5 L/min

Oxygen concentration (at 0.5 – 5 L/min) 93% +/- 3%

Electrical requirements 115/230 VAC, 50/60Hz

Power consumption approx. 290 Watt at 2 L/min; approx. 312 Watt at

5 L/min

Features
The simplified, two-piece cabinet design (compared to predicate device) allowed for 15% typical
sound quality improvement and an improved cooling process. Paired with patented DeVilbiss Turn-
Down Technology, these improvements minimize wear on internal components and increase the life
expectancy of the unit.
Patient safety/comfort features:
• Units are equipped with an Oxygen Sensing Device (OSD®) with oxygen flow measurement
capabilities.
• Visual and audible alarms for low oxygen levels, power failure, pressure drop and service
required
• Oxygen outlet incorporating a fire protection adapter
• Front label with easy to read pictograms
Environmentally friendly:
• Intelligent power management system utilises Turn-Down technology providing less power
consumption below flow rates of 2.5 L/min
Accessories
Many types of humidifiers, oxygen tubing and cannulas/masks can be used with the DeVilbiss 5 Liter
Oxygen Concentrator, although certain humidifiers and accessories may impair the device’s

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performance. A mask or any nasal cannula can be used with continuous flow delivery and may be
sized according to the patient’s prescription.
Intended use/indications for use (as stated in the DeVilbiss 525 Series Instruction Guide)
The DeVilbiss 5 Liter Oxygen Concentrator intended use is to provide supplemental low flow oxygen
therapy for patients suffering from COPD, cardiovascular disease, and lung disorders. The DeVilbiss
Concentrator is intended for use in home type environments, homes, nursing homes, patient care
facilities, etc.
The Instruction Guide recommends cleaning and disinfection of the device when there is a patient
change.

2.2 iGo Portable Oxygen Concentrator (base model 306)

Description of device
The iGo Portable Oxygen Concentrator (base model 306) is an oxygen concentrator of the pressure
vacuum swing adsorption (PVSA) type. The 306 Series is light weight and can operate on an external
battery pack, features which allow the 306 Series to be readily transported by the patient. The iGo
device also operates from AC and DC power.
The iGo Portable Oxygen Concentrator consists of pneumatic and electrical components. The system
has inlet filtration, air compressor, heat exchanger, and synthetic zeolite molecular sieve beds with a
pneumatic valve, outlet filtration, electronic flow control and audible/visual alarms.

Figure 2: iGo Portable Oxygen Concentrator with battery and AC/DC power supplies

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Operating principle
Like the DeVilbiss 5 Liter Oxygen Concentrator, the 306 iGo device is based on molecular sieve
technology.
However, the 306 iGo device has two operating modes: continuous product flow at up to 3 L/MIN and
pulse dosage mode at settings of 1to 6. In pulse dosage mode, the concentrator delivers a bolus of
oxygen when the start of inhalation is detected. This conserves the use of oxygen and also extends
battery life. The oxygen is delivered at each inhalation in an amount equal to 14cc times the setting
value. The integrated PulseDose® oxygen-conserving technology delivers brief and consistent bursts
of oxygen even at higher breath rates. According to the product literature, for many patients, these
short bursts are almost undetectable and more comfortable than continuous operation. PulseDose
also helps reduce throat and nasal dryness.
The continuous flow mode is recommended for use during sleep.
Components
The base catalogue number for the unit is 306DS. The base model includes the following parts:

Catalogue # Item

306DS Transportable Oxygen Concentrator

306D-413 2 battery packs

306DS-651 AC/DC adapter

306DS-612 Exhaust Muffler

306DS-616 Bacteria filter - installed

306DS-611 Air filter - installed

A-306-1, A-306-2 Instruction Guide

Specifications

Dimensions (H x W x D) 38 x 28 x 20 cm

Weight 8.6 kg with battery; 7.0 kg without battery

Settings 1 to 6 in PulseDose mode; 1 to 3 L/MIN in

Continuous Flow mode

Max. recommended continuous flow 3 L/MIN

Oxygen concentration 91% +/- 3% (all flow settings)

Operating temperature 5 - 40 deg C

Altitude 0-4,000 meters, tested @ approx. 933 hPa

Features
• As with the 5 Liter Oxygen Concentrator, built in OSD® (oxygen sensing device) ensures
accurate oxygen delivery and reduced periodic maintenance schedule

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• Increased Battery Capabilities – Can last as long as 5.4 hours when operating on setting 1 in
PulseDose Mode
• Audible alerts for Power Failure, Low Battery, Low Oxygen Output, High Flow/Low Flow, No
Breath Detected in PulseDose Mode, High Temperature, Unit Malfunction
• Can be used with 50 foot tubing/cannula in continuous flow mode and 35 foot tubing/cannula
in PulseDose mode
• Sound Level (3.0 PulseDose Mode) 40 dBA
• OxyTrack Software provides an integrated solution for viewing performance and usage
information on any DeVilbiss iGo Portable Oxygen System. With two software versions
available, it’s easy for technicians and clinicians to effectively monitor oxygen therapy.
OxyTrack provides: real-time unit performance monitoring; error logs; email/print reports;
patient usage history; compliance information
Accessories

Catalogue # Item

306D-413 Spare Li ion battery pack

306DS-651 Stand-alone AC battery charger / adapter

306DS-652 DC adapter

306DS-625 iGo rolling carrying case

306DS-626 iGo detachable wheeled cart

306DS-635 Deluxe iGo carrying case

306DS-627 Remote humidifier stand labelled (DO NOT USE

IN PULSE DOSE MODE)

Indications for Use (as stated in the DeVilbiss Model 306DS Instruction Guide)
The DeVilbiss Portable Oxygen Concentrator is intended to provide supplemental oxygen to persons
requiring low flow oxygen therapy. It is used at a patient's home or for their portable needs outside the
home and can also be used in institutions such as nursing homes or subacute care facilities.
The Instruction Guide recommends cleaning and disinfection of the device when there is a patient
change.

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3. Intended Therapeutic and/or Diagnostic Indications and Claims

3.1 Intended Therapeutic and/or Diagnostic Indications

3.1.1 Supplemental oxygen therapy

The following definitions of different forms of supplemental oxygen therapy are taken from the British
Thoracic Society’s guidelines for home oxygen use in adults (Hardinge et al., 2015).
Long-term oxygen therapy (LTOT) can be defined as oxygen used for at least 15 hours per day in
chronically hypoxaemic patients. Chronic hypoxaemia is defined as a PaO2 ≤7.3 kPa or, in certain
clinical situations, PaO2 ≤8.0 kPa. LTOT is delivered via an oxygen concentrator and should be
differentiated from the use of oxygen as a palliative measure for symptomatic relief in breathless
patients. A knowledgeable and experienced clinician should perform the initial assessment of the
patient who is beginning to receive LTOT.
Nocturnal oxygen therapy (NOT) is oxygen administered overnight alone without additional oxygen
therapy during awake or daytime hours. It is administered to patients who are either normoxic during
the day, or have mild daytime hypoxaemia but do not fulfil LTOT criteria.
Ambulatory oxygen therapy (AOT) is defined as the use of supplemental oxygen during exercise and
activities of daily living. In mobile patients who are not sufficiently hypoxaemic to qualify for LTOT but
who desaturate on exercise, AOT has historically been used to optimise saturations and short-term
exercise capacity. AOT is also often supplied to LTOT users, either to allow those who are mobile
outdoors to optimise their exercise capacity, or to enable more immobile patients to leave the house
in a wheelchair/scooter on occasion. AOT can be delivered from portable oxygen concentrators,
cylinders with compressed air or liquid oxygen cylinders.
The term “palliative oxygen therapy” (POT) refers to the use of oxygen to relieve the sensation of
refractory persistent breathlessness in advanced disease or life-limiting illness irrespective of
underlying pathology where all reversible causes have been or are being treated optimally.
Oxygen can be delivered in three basic ways: via concentrator, compressed oxygen gas, and liquid
oxygen. The least expensive and most efficient method to deliver oxygen therapy at home is via an
oxygen concentrator. Portable systems are used for AOT and are critical for maintaining
independence and quality of life for hypoxemic patients.

3.1.2 Patient groups requiring supplemental oxygen therapy

The main groups of patients requiring supplemental oxygen therapy are discussed in detail by
Hardinge et al. (2015). A brief overview follows:
Chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease (COPD) is a type of obstructive lung disease characterized by
persistent airflow limitation. It typically worsens over time. Patients with COPD can develop nocturnal
hypoxaemia due to ventilation–perfusion mismatch, decreased functional capacity and nocturnal
hypoventilation particularly pronounced during REM sleep. This in turn can lead to poor sleep quality
with sleep fragmentation. COPD is the only major cause of death whose incidence is on the
increase and is expected to be the third leading cause of death worldwide by 2030
(www.copdcoalition.eu/about-copd/key-facts). Patients with advanced COPD often require LTOT.
Studies carried out in the 1980s showed that LTOT treatment in appropriately selected patients can
improve survival rates by around 40%, irrespective of chronic hypercapnia and previous episodes of
oedema or pulmonary hypertension. Subsequent studies have confirmed that patients with clinically
stable COPD with chronic hypoxaemia have improved pulmonary haemodynamics and life
expectancy when treated with LTOT for at least 15 hours per day. LTOT has also been shown to
correct nocturnal SO2, decrease sleep latency and improve sleep quality for patients with COPD who
develop hypoxaemia (Eaton et al., 2001).

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Other diseases
Patients with respiratory diseases interstitial lung disease (ILD) and cystic fibrosis (CF) may develop
chronic hypoxaemia, leading to development of complications. The use of LTOT in patients with ILD
or CF may improve survival and tissue oxygenation, and prevent complications associated with
hypoxaemia such as worsening pulmonary hypertension.
Pulmonary hypertension may occur in a number of pulmonary vascular disorders. The use of LTOT in
non-COPD patients with pulmonary hypertension is to improve tissue oxygenation and to prevent
complications associated with hypoxaemia, such as worsening pulmonary hypertension, rather than
to afford a specific survival benefit. There is no evidence of the effectiveness of LTOT in patients with
pulmonary hypertension, with the exception of those patients who develop pulmonary hypertension as
a complication of their COPD. However, the use of LTOT in patients with pulmonary hypertension
may improve tissue oxygenation and prevent complications associated with hypoxaemia.
Patients with neuromuscular disorder or chest wall disease may develop nocturnal hypoventilation,
which causes nocturnal hypoxaemia and leads to chronic respiratory failure. LTOT is not generally
used in these patients, but may be used where there is co-existing airways disease or obesity causing
hypoxaemia which non-invasive ventilation alone does not correct.
Some patients with advanced cardiac failure may have resting hypoxaemia although hypoxaemia is
most consistently demonstrated during sleep in these patients. The use of LTOT in patients with
advanced cardiac failure and resting hypoxaemia may improve survival, tissue oxygenation and
prevent complications associated with hypoxaemia.
Nocturnal oxygen therapy (NOT) can be ordered for severe heart failure patients who do not fulfil
indications for LTOT, and have evidence of SDB leading to daytime symptoms, after other causes of
nocturnal desaturation have been excluded (e.g., obesity hypoventilation or obstructive sleep apnoea)
and heart failure treatment has been optimised.
Palliative oxygen therapy (POT) may on occasion be considered by specialist teams for patients with
intractable breathlessness unresponsive to all other modalities of treatment. It may relieve the
sensation of refractory persistent breathlessness in advanced disease or life-limiting illness
irrespective of underlying pathology where all reversible causes have been or are being treated
optimally.
Short burst oxygen therapy delivering high flow oxygen (12 L/min via a nonrebreather mask) is an
effective symptomatic treatment for acute cluster headache attacks. It should be noted that flows of
12 L/min cannot be achieved with DeVilbiss oxygen concentrators.

3.1.3 LTOT delivery from oxygen concentrators

A concentrator can either be fixed in a room in the house or is portable to go with the patient around
the home, outside the home and in the workplace. An oxygen concentrator is an electrically driven
device which takes room air and passes it through a filtering system, removing nitrogen, to supply an
oxygen enriched gas mixture (usually 85–95% oxygen). Performance of oxygen concentrators can
vary depending on the technology used.
Home concentrators are installed and regularly maintained by oxygen provider companies. All
concentrators should have fire breaks inserted into the tubing—one at the patient end and one at the
machine end—to reduce the risk of potentially catastrophic fires. Most oxygen concentrators deliver
flow rates of up to 4 L/min, adjustable in 0.5 L/min increments.
Pulse-dose oxygen delivery devices (PDOD), demand oxygen delivery systems (DODS) and other
types of oxygen-conserving devices may be used with oxygen concentrators and are normally
incorporated to extend the functional time or duration of use of the oxygen system. PDOD/DODS
devices are normally either electronic or mechanical (pneumatic) and may be time-cycled and/or
operate on demand, responding to a pressure drop triggered by the user’s inspiratory effort.
PDOD/DODS have varying performance characteristics, which include bolus volume, trigger
sensitivity and trigger response time.

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Transportable/portable concentrators are similar to home concentrators but smaller in size, weighing
up to 8.6 kg. They come with batteries as well as a mains attachment, allowing use outside as well as
inside the home. Inside the home, a transportable concentrator can be used as a standard
concentrator as well as fulfilling the patient’s ambulatory needs. The battery for use outside the home
does limit the time they can be used without recharging and will depend on the flow rate and whether
the pulsed mode is used. They can be used and charged in cars. Most are now approved for use on
commercial aircraft. Current models are available that deliver up to 3 L/min continuous oxygen and 6
L/min pulsed oxygen, and come with a power adapter to plug into an electrical source, or a battery
back-up.
Some portable oxygen concentrators provide both continuous and pulse flow options, for use while
the patient is sleeping or sedentary and to ambulate around the home and while traveling.
Portable oxygen concentrators weighing less than 4.5 kg (typically 3.3-4.5 kg) provide pulsed oxygen
only. Therefore, they are not suitable for use when sleeping.
Methods of oxygen pulse delivery
When not in continuous flow (if this is an option), all portable oxygen concentrators use an electronic
conserver that is built into the unit, thus all use a pulse delivery method. There are two methods of
pulse delivery:
• Minute Volume – this method delivers a fixed amount of oxygen per minute. The amount of
oxygen delivered with each breath depends on the breathing rate of the user. Slower
breathing rate equals larger amount of oxygen per breath; faster breathing rate equals smaller
amount of oxygen per breath.
• Uniform Pulse – this method delivers the same amount of oxygen with every breath,
regardless of the breathing rate. Slower breathing rate equals less oxygen over the course of
a minute; faster breathing rate equals more oxygen over the course of a minute.

3.1.4 Guidelines for home oxygen use in adults

The most recent guidelines for home oxygen use in adults have been issued by the British Thoracic
Society (BTS) in 2015 (Hardinge et al., 2015).
The BTS Home Oxygen Guideline provides evidence statements and recommendations for the use of
home oxygen for adult patients out of hospital. Although the majority of evidence comes from the use
of oxygen in patients with chronic obstructive pulmonary disease (COPD), the scope of the guidance
includes patients with a variety of long-term respiratory illnesses and other groups in whom oxygen is
currently ordered.
Grades of recommendations

Grade Type of evidence

A At least one meta-analysis, systematic review or RCT rated as 1++ and directly applicable to the target
population or A systematic review of RCTs or a body of evidence consisting principally of studies rated
as 1+ directly applicable to the target population and demonstrating overall consistency of results

B A body of evidence including studies rated as 2++ directly applicable to the target population and
demonstrating overall consistency of results or Extrapolated evidence from studies rated as 1++ or 1+

C A body of evidence including studies rated as 2+ directly applicable to the target population and
demonstrating overall consistency of results or Extrapolated evidence from studies rated as 2++

D Evidence level 3 or 4 or Extrapolated evidence from studies rated as 2+

√ Important practical points for which there is no research evidence, nor is there likely to be any research
evidence. The guideline committee wishes to emphasise these as Good Practice Points.

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Grade Evidence

1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias

1+ Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

1− Meta-analyses, systematic reviews of RCTs, or RCTs with a high risk of bias

2++ High quality systematic reviews of case–control or cohort studies or high quality case–control or cohort studies with a
very low risk of confounding, bias or chance and a high probability that the relationship is causal

2+ Well conducted case–control or cohort studies with a low risk of confounding, bias or chance and a moderate
probability that the relationship is causal

2− Case–control or cohort studies with a high risk of confounding, bias or chance and a significant risk that the
relationship is not causal

3 Non-analytic studies, for example case reports, case series

4 Expert opinion

RCT: randomised control trial

Selected evidence statements (full list can be found in the BTS Home Oxygen Guideline)

Evidence statement Evidence

level

Patients whose clinical condition is stable with a resting PaO ≤7.3 kPa have improved life 1+
expectancy when treated with LTOT for at least 15 h/day.

Patients with stable COPD and a resting PaO2 ≤8.0 kPa with evidence of cor pulmonale, 1+
polycythaemia and/or pulmonary hypertension have improved outcomes with LTOT.

Use of continuous oxygen therapy (24 h) offers additional survival benefit compared to shorter 1−
durations (12–15 h) but can contribute to higher PaCO2 levels.

Use of LTOT in hypercapnic respiratory patients with COPD does not lead to increased morbidity, 1+
mortality or healthcare utilisation.

Selected Recommendations (full list can be found in the BTS Home Oxygen Guideline)

Recommendation Grade

Patients with stable COPD and a resting PaO2 ≤7.3 kPa should be assessed for LTOT, which offers A
survival benefit and improves pulmonary haemodynamics.

LTOT should be ordered for patients with stable COPD with a resting PaO2 ≤8 kPa with evidence of A
peripheral oedema, polycythaemia (haematocrit ≥55%) or pulmonary hypertension.

LTOT should be ordered for patients with resting hypercapnia if they fulfil all other criteria for LTOT. B

Patients with a resting stable oxygen saturation (SpO2) of ≤92% should be referred for a blood gas C
assessment in order to assess eligibility for LTOT.

Patients should undergo formal assessment for LTOT after a period of stability of at least 8 weeks from B
their last exacerbation

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LTOT should be ordered for a minimum of 15 h per day, and up to 24 h per day may be of additional C
benefit.

Patients eligible for LTOT should be initiated on a flow rate of 1 L/min and titrated up in 1 L/min B
increments until SpO2 >90%. An ABG should then be performed to confirm that a target PaO2 ≥8 kPa
(60 mm Hg) at rest has been achieved.

Patients initiated on LTOT who are active outdoors should receive an ambulatory oxygen assessment to B
assess whether their flow rate needs increasing during exercise.

Oxygen concentrators should be used to deliver LTOT at flow rates of 4 L/min or less. B

Portable oxygen should be delivered by whatever mode is best suited to the individual needs of the C
patient to increase the daily amount of oxygen used and activity levels in mobile patients.

The type of portable device selected should balance patient factors with cost effectiveness, resources √
and safety.

Patients initiated on LTOT should be provided with formal education by a specialist home oxygen D
assessment team to ensure compliance with therapy.

3.1.5 Paediatric use of oxygen concentrators

The paediatric use of DeVilbiss oxygen concentrators is determined by the physician and the medical
providers. Paediatric use requires low flows. DeVilbiss markets a flow meter that can be used with its
oxygen concentrators to provide low flows (1/8th litre increments) and the providers can use that flow
meter when the physician prescribes use of an oxygen concentrator for paediatric use.
The British Thoracic Society issued separate guidelines for home oxygen use in children in 2009
which remain unchanged (Balfour-Lynn et al., 2009).
The range of conditions seen in children is quite distinct from adults. There is a tendency for children’s
diseases to improve with time, whereas with adults they tend to deteriorate. Exceptions in children
include cystic fibrosis and neuromuscular disease.
Oxygen concentrators should be provided for LTOT, unless it is likely that the child will only require
low flow oxygen for a short while. There is no evidence available to support whether an oxygen
concentrator or cylinder is best for use in children. Oxygen concentrators are usually the preferred
devices with large back-up cylinders for breakdown or power cuts. Low flow meters are preferable,
but very low flow meters are not recommended. Low flow meters (0.1–1 L/min) must be available for
infants and very young children.

3.2 Safety and/or Performance Claims

Safety and performance claims for the DeVilbiss oxygen concentrator devices (models 525 and 306)
are in line with the Indications for Use presented in Section 2.1 and 2.2.
No additional specific safety or performance claims are made for the device in the Instruction Guides.

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4. Context of the Evaluation and Choice of Clinical Data Types

4.1 Developmental Context
History of the technology
DeVilbiss 5L Oxygen Concentrator model 525 is produced to a well-known design. The current 525
model was introduced into the market in February 2008, but substantially equivalent predecessor
devices have been on the market for over 15 years. Due to continuing improvements the current
compact 525 model incorporates an expanded range of safety features. There are many similar
competitor stationary oxygen concentrator devices on the market, including Respironics EverFlo,
Invacare Perfecto2 V, AirSep VisionAire and Caire Companion 5.
The iGo (model 306) oxygen concentrator was introduced into the market in January 2009. These
devices are produced to well-known designs. Comparable devices on the market deliver both
continuous and pulse flow. They include Respironics SimplyGo, InvaCare SOLO2, SeQual Eclipse 5,
and OxLife Independence. These devices are similar to stationary oxygen concentrators but smaller
in size, weighing up to 8.6 kg. There are also smaller portable devices, weighing less than 4.5 kg, that
only deliver pulse flow oxygen.
Essential Requirements
Please refer to the Essential Requirements Checklist included in the Technical File.

4.2 Justification of Clinical Data Type

According to MEDDEV 2.7.1 Rev.3 (2009) guidelines (section 5.1) clinical evaluation of medical
devices that are based on existing, well established technologies and intended for an established use
of the technology is most likely to rely on compliance with recognized standards and/or literature
review and/or clinical experience with the device or equivalent devices.
DeVilbiss oxygen concentrators (models 525 and 306) have been on the market since 2008/2009.
There is also long-term commercial experience with similar devices on the market. The clinical safety
and performance of DeVilbiss oxygen concentrators are therefore evaluated based on: compliance
with recognized standards; a literature review; and post-market surveillance data:
• The recognized standards to which compliance is claimed are listed in the Declaration of
Conformity documents issued on 23 September 2014.
• Data generated through literature search that relates directly to the devices in question or to
equivalent devices (MEDDEV 2.7.1, Rev,3, Section 6.1); and
• Post-market surveillance data: clinical experience with the DeVilbiss oxygen concentrators
and equivalent devices on the market (section 6.2 MEDDEV 2.7.1 Rev 3, Section 6.2). This
includes customer complaints made directly to DeVilbiss for both oxygen concentrators (
models 525 and 306) and reports of suspected device-associated adverse events and
malfunctions for the equivalent devices recorded in FDA’s MAUDE database.
The Literature Review Report (Appendix A) contains details specific to the Literature Search
Methodology and the Results of the Methodology. In addition, the Search of Key Words can be found
in Appendix B.
The internal complaint summary and the output of the search of the MAUDE database for equivalent
devices are provided in Appendix G.

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4.3 Justification of Equivalent Devices

The tables below detail the similarities and differences among the oxygen concentrator devices that
feature in the articles evaluated in section 6 (“Data Analysis”) of this CER. The analysis of
equivalence is bbased on MEDDEV 2.7.1. Rev.3 Guidelines on Medical Devices (section 3.2.3).

Table 1 Stationary oxygen concentrators

Device manufacturer/name GAP

DeVilbiss/ Respironics/ Puritan

Bennett/
5L Oxygen EverFlo
Concentrator Companion
(model 525) 492a
Device characteristics

CLINICAL

Used for the same clinical used to provide used to provide used to provide No
condition or purpose supplemental supplemental low supplemental low
low flow oxygen flow oxygen flow oxygen
therapy therapy therapy

Used at the same site in the pulmonary pulmonary pulmonary No

body delivery via a delivery via a delivery via a
nasal cannula nasal cannula nasal cannula

Used in a similar population patients with low patients with low patients with low No
(including age, anatomy, blood oxygen blood oxygen blood oxygen
physiology) saturation levels saturation levels saturation levels

Have similar relevant critical expected to expected to expected to No

performance according to improve improve improve
expected clinical effect for symptoms symptoms symptoms
specific intended use associated with associated with associated with
hypoxaemia hypoxaemia hypoxaemia

TECHNICAL/Functional

Used under similar conditions stationary device stationary device stationary device No
of use for home type for home type for home type
environments environments environments

Have similar specifications and

properties:

Oxygen flow 0.5-5 L/min 0.5-5 L/min 0-4 L/min Yes

Oxygen purity 93%+/-3% 93%+/-3% 95%+/-3% (at 1-3 Yes

L/min)
92%+/-3% (at 4
L/min)

Weight (kg) 16.3 14.0 25.6 Yes

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Dimensions WxHxD (cm) 34x62x30 38x58x24 32x65x42 No

(similar)

Materials used (raw material Contains Contains Contains No

and final) synthetic zeolite synthetic zeolite synthetic zeolite

Source and composition of N/A - the unit is N/A - the unit is N/A - the unit is No
materials used not in contact not in contacts not in contacts
with the patient with the patient with the patient

Of similar design Compact cabinet Compact cabinet Compact cabinet No

consists of consists of consists of
pneumatic and pneumatic and pneumatic and
electrical electrical electrical
components components components

Use similar deployment Used with a Used with a Used with a No

methods (if relevant) plastic cannula plastic cannula plastic cannula

Have similar principles of Based on Based on Based on No

operation molecular sieve molecular sieve molecular sieve
technology technology technology

BIOLOGICAL

Use same biocompatible The basic unit is The basic unit is The basic unit is No
materials in contact with the not in contact not in contact not in contact
same human tissues or body with human with human with human
fluids tissues or body tissues or body tissues or body
fluids fluids fluids

Animal-origin materials present No No No No

Presence of human blood No No No No

derivatives

Information used to populate the table above has been sourced from the devices’ Instructions for Use,
510k summaries, marketing brochures and published studies (Appendix D).
Comments on the significance of the findings: The key performance descriptor for the oxygen
concentrator devices is the oxygen purity performance at .5-5 L/M of oxygen output.
There are slight differences between the three stationary, compact devices but any GAPs are not
substantial. EverFlo is an equivalent device. There are only small differences between the DeVilbiss
525 device and Companion 492a. The latter device is the subject of a study described in section
6.1.2. employing flows of 2 L/min. The Companion 492a device will be considered “equivalent” to the
DeVilbiss 525 device for the purposes of this evaluation.

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Table 2 Portable oxygen concentrators

Device manufacturer/name GAP

DeVilbiss/ SeQual/ Respironics/

iGo Oxygen Eclipse 3 EverGo
Concentrator
(model 306)
Device characteristics

CLINICAL

Used for the same clinical used to used to used to provide No

condition or purpose provide provide supplemental
supplemental supplemental low flow
low flow low flow oxygen therapy
oxygen oxygen
therapy therapy

Used at the same site in pulmonary pulmonary pulmonary No

the body delivery via a delivery via a delivery via a
nasal cannula nasal cannula nasal cannula

Used in a similar patients with patients with patients with No

population (including age, low blood low blood low blood
anatomy, physiology) oxygen oxygen oxygen
saturation saturation saturation
levels levels levels

Have similar relevant expected to expected to expected to No

critical performance improve improve improve
according to expected symptoms symptoms symptoms
clinical effect for specific associated associated associated with
intended use with with hypoxaemia
hypoxaemia hypoxaemia

TECHNICAL/Functional

Used under similar for the for the for the patient’s No
conditions of use patient’s patient’s portable needs
portable needs portable outside the
outside the needs outside home as well as
home as well the home as home use
as home use well as home
use

Have similar specifications

and properties:

Oxygen delivery method Continuous up Continuous up N/A Yes (EverGo)

to 3 L/min; to 3 L/min;
Pulse-dose
Pulse-dose Pulse-dose settings 1-6
settings 1-6 settings 1-6

Oxygen pulse-dose bolus 14-84 16-192 12-70 Yes (Eclipse 3)

volume, ml

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Oxygen purity 91%+/-3% (all 90%+/-3% 89%+/-3% No

flow settings)

Trigger sensitivity,cm H 2 O -0.05 to -0.12 -0.15 to 0.45 -0.2 Yes

Weight (kg) 8.6 with one 8.4 with one 4.5 with two Yes (EverGo)
battery battery batteries

Dimensions WxHxD (cm) 28x38x20 31x49x18 15x22x31 Yes (EverGo)

Materials used (raw Contains Contains Contains No

material and final) synthetic synthetic synthetic
zeolite zeolite zeolite

Source and composition of N/A - the unit N/A - the unit N/A - the unit is No
materials used is not in is not in not in contacts
contact with contacts with with the patient
the patient the patient

Of similar design Compact Compact Compact No

cabinet cabinet cabinet
consists of consists of consists of
pneumatic and pneumatic and pneumatic and
electrical electrical electrical
components components components

Use similar deployment Used with a Used with a Used with a No

methods (if relevant) plastic cannula plastic cannula plastic cannula

Have similar principles of

operation:

Oxygen purification based on based on based on No

molecular molecular molecular sieve
sieve sieve technology
technology technology

Operating modes both both pulse flow only Yes (EverGo)

continuous continuous
and pulse flow and pulse flow

Pulse flow method Uniform Pulse Uniform Pulse Uniform Pulse No

(fixed volume (fixed volume (fixed volume
of oxygen per of oxygen per of oxygen per
pulse) pulse) pulse)

BIOLOGICAL

Use same biocompatible The basic unit The basic unit The basic unit No
materials in contact with is not in is not in is not in contact
the same human tissues or contact with contact with with human
body fluids human tissues human tissues tissues or body
or body fluids or body fluids fluids

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Animal-origin materials No No No No
present

Presence of human blood No No No No

derivatives

Information used to populate the table above has been sourced from the devices’ Instructions for Use
(IFU), 510k summaries, marketing brochures and published studies (Appendix D).
Comments on the significance of the findings: All three devices can deliver pulse flow oxygen and
all deliver uniform pulse. The main differences between the devices are highlighted. When operating
in the pulse mode, the main difference is the maximum volume of the oxygen pulse that can be
delivered. With the exception of the differences highlighted, the three devices are considered
equivalent for pulse dose oxygen delivery with respect to their other characteristics.

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Table 3 Portable oxygen concentrators (contd.)

Device manufacturer/name GAP

DeVilbiss/ Inogen/ CAIRE/

AirSep
iGo Oxygen Inogen One LifeStyle
Concentrator G2
(model 306) (superseded
by AirSep
Device characteristics FreeStyle)

CLINICAL

Used for the same clinical used to used to used to No

condition or purpose provide provide provide
supplemental supplemental supplemental
low flow low flow low flow
oxygen oxygen oxygen
therapy therapy therapy

Used at the same site in pulmonary pulmonary pulmonary No

the body delivery via a delivery via a delivery via a
nasal cannula nasal cannula nasal cannula

Used in a similar patients with patients with patients with No

population (including age, low blood low blood low blood
anatomy, physiology) oxygen oxygen oxygen
saturation saturation saturation
levels levels levels

Have similar relevant expected to expected to expected to No

critical performance improve improve improve
according to expected symptoms symptoms symptoms
clinical effect for specific associated associated associated
intended use with with with
hypoxaemia hypoxaemia hypoxaemia

TECHNICAL/Functional

Used under similar for the for the for the No

conditions of use patient’s patient’s patient’s
portable needs portable portable needs
outside the needs outside outside the
home as well the home as home as well
as home use well as home as home use
use

Have similar specifications

and properties:

Oxygen delivery method Continuous up Continuous: Continuous: Yes

to 3 L/min; N/A N/A
Pulse-dose Pulse-dose Pulse-dose
settings 1-6 settings 1-5 settings 1-5

Oxygen pulse-dose bolus 14-84 N/A No data for Yes

volume, ml settings

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Oxygen purity 91%+/-3% (all 90%-3% / +6% 90%+/-3% (all No

flow settings) (all flow flow settings)
settings)

Trigger sensitivity (cm -0.05 to -0.12 -0.12 no data Yes

H 2 O)

Weight (kg) 8.6 with one 3.2 with one 4.4 Yes
battery battery

Dimensions WxHxD (cm) 28x38x20 10x24x27 18x14x41 Yes

Materials used (raw Contains Contains Contains No

material and final) synthetic synthetic synthetic
zeolite zeolite zeolite

Source and composition of N/A - the unit N/A - the unit N/A - the unit No
materials used is not in is not in is not in
contact with contacts with contacts with
the patient the patient the patient

Of similar design Compact Compact Compact No

cabinet cabinet cabinet
consists of consists of consists of
pneumatic and pneumatic and pneumatic
electrical electrical and electrical
components components components

Use similar deployment Used with a Used with a Used with a No

methods (if relevant) plastic cannula plastic cannula plastic
cannula

Have similar principles of

operation:

Oxygen purification based on based on based on No

molecular molecular molecular
sieve sieve sieve
technology technology technology

Operating modes both pulse flow only pulse flow Yes

continuous only
and pulse flow

Pulse flow method Uniform Pulse Fixed Minute Uniform Pulse Yes
(fixed volume Volume (fixed (fixed volume
of oxygen per amount of of oxygen per
pulse) oxygen per pulse)
minute)

BIOLOGICAL

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Use same biocompatible The basic unit The basic unit The basic unit No
materials in contact with is not in is not in is not in
the same human tissues or contact with contact with contact with
body fluids human tissues human tissues human
or body fluids or body fluids tissues or
body fluids

Animal-origin materials No No No No
present

Presence of human blood No No No No

derivatives

Information used to populate the table above has been sourced from the devices’ Instructions for Use
(IFU), 510k summaries, marketing brochures and published studies (Appendix D).
Comments on the significance of the findings: Only iGo delivers both continuous and pulse flow
oxygen. There are a few other differences between the devices. The main difference is that Image
One delivers fixed amounts of oxygen per minute, while iGo and AirSep LifeStyle both deliver fixed
volume of oxygen per pulse.

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5. Summary of the Clinical Data and Appraisal

The following clinical data sets have been used in the clinical evaluation of DeVilbiss oxygen
concentrators (models 525 and 306):

Safety Data Performance Data

2 Publications 4 Publications

Customer Complaints:
• Oxygen Concentrator model 525
• Oxygen Concentrator model 306

Reports of adverse events in FDA’s MAUDE:

• DeVilbiss concentrators (models 525 and
306) – no reports
• 2 equivalent devices

Details of the table above, along with data appraisal methods used in the evaluation, including any
weighting criteria, and a summary of the key results can be found in the following appendixes:

• Data generated through literature search (Appendixes A, B, C, D and E)

• Post market surveillance report (Appendix G)
• Risk management reports (Appendix I)

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6. Data Analysis
6.1 Description of analysed data used to assess the device safety

6.1.1 Literature review

6.1.1.1 Devices of concern

DeVilbiss’ oxygen concentrators are intended for long term use by patients, and therefore the features
they possess must ensure their safe operation. An early study evaluated the features of six stationary
oxygen concentrators, including DeVO2, a predecessor to the current 525 model, in the laboratory
(Johns et al., 1985).
The study concluded that the main disadvantage of concentrators compared with cylinders is the
possibility of machine failure or power failure. However, this risk can be minimized if a stock of spare
parts and a standby machine centrally located are readily available.
The study also highlighted significant differences between the models tested as regards safety
features. It should be noted that many of these devices are now outdated and technology has
superseded them. The investigators concluded that, in addition to safety features relating to electric
shock hazard and fire hazard, other safety features may be considered desirable, including:
• Purity of the gas: (i) Outlet filter to exclude the possibility of sieve material reaching
the patient; (2) Inlet filter(s) for both dust and bacteria.
• Dosage (and maintenance scheduling) Time elapsed meter
• Correct function (i) Visual and audible alarms to include indication of (a) power failure
and (b) inlet filter blockage/system pressure failure. (ii) Alarm test facility whereby the
integrity of the battery powering the alarm can be checked. (iii) Power on-off switch
that illuminates when in the on position.
The DeVO2 was one of DeVilbiss original models that was manufactured from 1979 to 1981. It had
most of the desirable safety features, but lacked visual alarms. Current models have visual and
audible alarms that are tested and those tests are documented in the Device History Records as the
units are assembled. They also incorporate an oxygen sensing device and low oxygen alarm.

6.1.1.2 Equivalent devices

Risk of uncorrected hypoxaemia with the use of stationary oxygen concentrators

In hypoxaemic patients with chronic respiratory disease formal assessment of long term oxygen
therapy (LTOT) is required which is usually conducted in the hospital and performed on wall (piped)
oxygen to ensure correction of the hypoxaemia. However, an oxygen concentrator is the standard
oxygen source for the patient at home who requires LTOT. The oxygen concentration delivered is
lower from a concentrator than piped oxygen.
Bolton et al. (2006) carried out a study of ten hypoxaemic patients using both delivery sources in a
cross-over design. Patients were randomly commenced on either wall oxygen (five of 10 patients) or
an oxygen concentrator (Puritan Bennett Companion 492a). The concentration of oxygen delivered by
the concentrator was measured on two occasions, 12 months apart, during the study period. The
patients received oxygen for 30 minutes at a flow rate of 2L/min, via nasal cannulae following which a
blood gas sample was taken and analysed immediately. The method of oxygen delivery was then
reversed and further blood gas samples were taken after 30 minutes. Finally the patient was given the
original source for 30 minutes and the last blood gas samples taken. The flow rate was always
maintained at 2L/min via the nasal cannulae. The PaO 2 of the patients on both the concentrator and
wall oxygen were compared. The mean difference of 6.4 mmHg (=0.84 kPa) between the sources
was significant at P = 0.02, regardless of which source was used first.

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Although this was a small study, it demonstrated significantly lower PaO 2 measured in the patients
who were receiving oxygen via a concentrator compared to wall oxygen. This suggests that clinicians
should consider formally assessing patients on an oxygen concentrator in order to ensure that the
hypoxaemia will be corrected when they are prescribed a concentrator for home use. Continuing to
conduct the assessments on wall oxygen, whilst prescribing a concentrator for home use could lead
to uncorrected hypoxaemia with potential survival implications if a PaO 2 greater than 60mmHg is not
achieved. As different types of concentrators deliver slightly different concentrations of oxygen, the
ideal assessment would be performed on the same make and model as the patient would have at
home.
Use of portable pulsed-dose oxygen concentrators during sleep
Despite the widespread use of pulsed-dose oxygen concentrators in awake and ambulating patients,
few studies report their use during sleep. A common concern regarding their use during sleep is the
effect of slower respiratory rate and smaller tidal volume (hypoventilation) on oxygenation. In a study
conducted by Chatburn et al. (2006), Inogen One was able to maintain adequate oxygen saturation
(SpO 2 ) during sleep comparable to continuous-flow oxygen in 9 of 10 patients. The authors attribute
this finding to the fact that Inogen One operates on the “fixed minute volume” principle; the device has
a microprocessor that monitors the respiratory rate and adjusts the bolus volume to maintain a
consistent minute volume of oxygen. Lobato et al. (2011) caution against the use of Inogen One
connected to a non-invasive ventilator (NIV) at night. The authors speculate that NIV may hinder
triggering of portable oxygen concentrators.
The finding of safe use of Inogen One during sleep cannot be extrapolated to oxygen concentrators
that operate on the “uniform pulse volume” principle (such as iGo).

6.1.2 Post-market surveillance data (DeVilbiss)

Complaints, CAPAs and recalls (DeVilbiss L Liter Oxygen Concentrator model 525)
The overall complaints rate for the 5 Liter Oxygen Concentrator over the period 1 January 2012 – 19
June 2015 was 3.4% per unit sold (Appendix G). No patient effect was noted in the complaints. The
most frequently reported issues for the 5 Liter Oxygen Concentrator were sieve bed issues (23.0%)
and compressor issues (15.8%).
There were no CAPAs or recalls on the 5 Liter Oxygen Concentrator during the period 1 January
2012 – 19 June 2015.
There were no records identified in the MAUDE database involving the 5 Liter Oxygen Concentrator
during the period 1 January 2012 – 19 June 2015.
Complaints, CAPAs and recalls (iGo Portable Oxygen Concentrator model 306)
The overall complaints rate for the iGo Portable Oxygen Concentrator (model 306) over the period 1
January 2012 – 19 June 2015 was 9.3% per unit sold (Appendix G). No patient effect was noted in
the complaints. The most frequently reported issues for the iGo Portable Oxygen Concentrator were
key pad issues (32.6%), valve issues (17.4 %), and sieve bed issues (14.2%).
There were no CAPAs or recalls on the iGo Portable Oxygen Concentrator during the period 1
January 2012 – 19 June 2015.
There were no records identified in the MAUDE database involving the iGo Portable Oxygen
Concentrator during the period 1 January 2012 – 19 June 2015.

6.1.3 Post-market surveillance data (equivalent devices)

Searches were carried out for equivalent devices in the FDA’s MAUDE database over the period 1
January 2012 to 19 June 2015.

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Respironics EverFlo
Respironics EverFlo is a device equivalent to DeVilbiss 5L Oxygen Concentrator model 525 (see
section 4.3, Table 1). Seventy reports of individual events were identified for EverFlo that occurred
within the specified timeframe. Of these 70 reports, 11 described patient deaths, 39 described patient
injuries and 20 described device malfunctions.
Smoking was found to be a contributing factor in two of the incidents resulting in patient death.
Product labeling instructs not to smoke while using the device. There was one case in which a power
outage caused the EverFlo device to stop functioning and the patient was unable to utilize their
backup oxygen. In the remaining eight cases it was not possible to determine definitive device
involvement in the patient deaths.
There were 39 reports of injuries for Respironics EverFlo device. The most frequently reported injury
involved smoking while using the device (nine reports). There were eight reports that the device may
have caused or exacerbated a medical condition, but no definitive evidence was provided linking the
device to the medical condition. There were eight reports of injuries resulting from issues with oxygen
delivery; two of these were confirmed as due to device malfunctions. There were six reports of fire
events involving the device, but the device was not returned for evaluation in four of the reported
events; the device was found not to have caused or contributed to the fire in the other two cases.
There were three reports of injuries resulting from a solenoid valve issue. The remaining five injuries
were due to miscellaneous issues.
Full details of all of the MAUDE findings can be found in Appendix G.
Respironics EverGo
Respironics EverGo is a device equivalent to DeVilbiss iGo portable Oxygen Concentrator model 306
(see section 4.3, Table 2). Eight records were identified for EverGo. All described device
malfunctions. Of these eight records, two described device malfunctions that did not result in patient
injury and six described device malfunctions that did result in patient injury.
Full details of all of the MAUDE findings can be found in Appendix G.

6.2 Description of analysed data used to assess the device performance

6.2.1 Literature review

6.2.1.1 Devices of concern

Meeting oxygen needs during exercise (iGo)

Patients with chronic lung disease using long term oxygen therapy benefit from an active lifestyle, and
portable oxygen systems are of particular interest to this patient population. Leblanc et al. (2013)
compared the ability of 3 portable oxygen concentrators (POCs) to maintain SpO 2 > 90% during
exercise in patients with chronic lung disease. Twenty-one subjects with chronic lung disease (18 with
COPD, 3 with pulmonary fibrosis) and documented room air exertional SpO2 < 85% performed four 6-
min walk tests: a control walk using the subject’s current oxygen system and prescribed exertional
flow rate, and one walk with each of the 3 POCs (iGo, Eclipse 3, and EverGo) at their maximum
pulse-dose setting. The order in which POCs were used was randomly assigned for each subject.
Each 6-min walk test was separated by a minimum 20-min rest period. Subjects were placed on the
assigned POC 10 minutes prior to the next walk. SpO 2 was measured continuously during the walk.
The therapist terminated a walk if the subject’s SpO 2 reached <85% for any length of time. SpO 2 was
significantly higher pre-walk and post-walk with the Eclipse 3, compared to the other POCs (all P <
0.01). The subjects also walked farther and maintained a mean SpO 2 > 90% with the Eclipse 3 (both
P <0.01). The authors suggested that the larger oxygen pulse bolus volume of the Eclipse 3 was an
important contributing factor enabling it to better meet the subjects’ oxygen needs during exercise.
The authors concluded that users of portable oxygen concentrators should be appropriately tested
during all activities of daily living, to ensure adequate oxygenation. The healthcare provider should

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provide information and help to direct the subject toward the most clinically appropriate oxygen
system, while being mindful of the patient’s preferences and lifestyle.

6.2.1.2 Equivalent devices

Meeting oxygen needs during exercise (portable oxygen concentrators)

Nasilowski et al. (2008) conducted a randomised, single-blind clinical trial involving 13 COPD patients
with respiratory failure. The aim of the study was to determine if a portable oxygen concentrator
delivering a uniform pulse of oxygen (AirSep LifeStyle) is as effective as liquid oxygen in reducing
exercise-induced hypoxaemia in severe COPD patients on long term oxygen therapy.
All patients underwent a series of 6-min walk tests carried out in random order among one of the
three devices: AirSep LifeStyle portable oxygen concentrator, liquid oxygen cylinder (LOC) and
cylinder with compressed air (CA). Oxygen supplementation was 3 L/min for LO and an equivalent to
3
3 L/min in AirSep LifeStyle (at this setting the bolus according to manufacturer is 26.25 cm ; it should
be noted that the total amount of inhaled oxygen per minute depends on bolus amount and number of
breaths).
The mean SpO 2 was equally improved at rest: 92.9%+/-2.8% with LifeStyle and 91.7%+/-2.0% with
LO compared 87.8%+/-2.7% with CA (LifeStyle and LO vs. CA p<0.05). LifeStyle and LO significantly
improved oxygenation during 6-min walk test (mean SpO 2 was 84.3%+/-5% and 83.8%+/-4.2%,
respectively) compared to breathing CA 77.6%+/-7.4%, p<0.05. These results suggest that the effects
of oxygen supplementation with LifeStyle device did not differ from the LO portable units during the 6-
min walk test in walking distance and SpO 2 . It appears that the LifeStyle device may be safely used
for ambulatory oxygen treatment.
The mean oxygen flow prescribed for patients in this study in resting condition was 1.7+/-0.7 L/min.
The study showed that continuous flow or equivalent to 3 L/min of oxygen, which corresponded
approximately to doubling resting dose, did not prevent hypoxaemia during strenuous exercise.
However, it may be sufficient during less vigorous activities of daily life. The authors suggested that in
order to prevent hypoxaemia during strenuous exercise three-fold increase of oxygen flow should be
prescribed.

6.3 Product Literature and Instructions for Use

All residual risks identified through the risk activities performed by the manufacturer during product
development to evaluate the two oxygen concentrators (model 525 and model 306) have been
addressed during the development of DeVilbiss oxygen concentrators (models 525 and 306) (525
Oxygen Concentrator Risk Management Report Rev 1, issued 1/3/2008; and 306D Oxygen
Concentrator, issued 10/10/2008). The DeVilbiss 5 Liter Oxygen Concentrator Instruction Guide and
the DeVilbiss iGo Model 306 Instruction Guide carry comprehensive safety information about hazards
(in particular, fire) that may arise due to improper use of the equipment and that could result in serious
injury or death. Both Instruction Guides describe a wide range of safety features incorporated into the
design of these devices.
Both guides stress that the oxygen concentrators must be used according to the prescription
determined by the patient’s physician and the patient is cautioned not to increase or decrease the flow
of oxygen.
Both guides follow established guidelines in instructions/warnings/cautions/notes for the users of the
devices. The iGo Model 306 Instruction Guide also follows guidelines in its instructions to the
physician’s/respiratory therapists. These instructions are as follows:
1. Use only continuous flow mode of operation with patients who breathe below 6 Breaths Per Minute
(BPM); refer to specifications for maximum breath rate.
2. Use only continuous flow mode of operation with patients who consistently fail to trigger equipment
(i.e. mouth breathing with closed soft palates).

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3. PulseDose settings should be determined for each patient individually. Settings from continuous
flow applications may not be applicable to PulseDose mode.
4. Verify patient is getting adequate Pa02 or Sa02 levels in PulseDose delivery mode.
5. Use only standard nasal cannula with PulseDose delivery. Do not use pediatric (low-flow) nasal
cannula with PulseDose delivery. Any nasal cannula can be used with continuous flow delivery.
6. PulseDose settings should be determined for each patient individually. Settings from Continuous
Flow applications may not be applicable to PulseDose Mode.
7. Do not use with other equipment (i.e. humidifier, nebulizer, etc.) when in PulseDose delivery mode.
Further in the 306 Instruction Guide “Operating your iGo” the instructions 5-7 above are repeated for
the patients’ benefit. The following warnings are highlighted:
WARNING: As with conserving devices, the iGo may not be able to detect some respiratory efforts in
PulseDose mode.
WARNING: Under certain circumstances, oxygen therapy can be hazardous. Seeking medical advice
before using an oxygen concentrator is advisable. It is very important to follow your oxygen
prescription. Do not increase or decrease the flow of oxygen - consult your physician.
Suggested improvements to assessments of portable devices
The articles retrieved in the literature search and analysed in section 6.1 and 6.2 suggest
improvements to the way assessments of portable pulse delivery devices are made by the clinicians.
These suggestions have not yet been incorporated into official guidelines. The prescribing clinicians
are to urged to consider formally assessing patient on an oxygen concentrator that is being prescribed
rather than wall oxygen to ensure that hypoaemia will be corrected (Leblanc et al. (2013) and testing
individual patients’ needs during typical exercise activities to ensure adequate oxygenation (Leblanc
et al. (2013).
Use of the iGo (model 306) oxygen concentrator during sleep
A common concern regarding the use of portable oxygen concentrators in the pulse dose mode
during sleep (the effect of slower respiratory rate and smaller tidal volume on oxygenation). The
literature review provides support for the use of devices operating on the constant minute volume
principle only (Chatburn et al., 2006). The iGo Model 306 Instruction Guide does not contain any
information about use of the portable device during sleep, but the website www.igopoc.com
recommends the continuous flow mode for use during sleep. The iGo Model 306 Instruction Guide
does carry the following information for the patient: “When operating in PulseDose mode, an alert will
beep after 30 seconds if a breath is not detected. If another 60 seconds elapses and no breath is
detected, the unit will switch to Continuous Flow at the last Continuous Flow setting used”.

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7. Post Market Surveillance and Clinical Follow-Up

Post Market Clinical Follow-up (PMCF), in accordance with MEDDEV 2.12.2 is considered for devices
where identification of possible emerging risks and the evaluation of long term safety and
performance are critical. In identifying such emerging risk, the following checklist has been completed
for the DeVilbiss Oxygen Concentrators (models 525 and 306).
It should be noted that PMCF studies may not be required when the medium/long-term safety and
clinical performance are already known from historical use of the device or where other appropriate
post-market surveillance activities would provide sufficient data to address the risks.
(When answering the following questions, new is defined as the product having a new indication for use
which is not cleared/approved for any other device in the market.)

Risk Criteria that may justify a PMCF study: Yes No NA

• innovation, e.g., where the design of the device, the materials, substances, the No
principles of operation, the technology or the medical indications are novel

• significant changes to the products or to its intended use for which premarket No
clinical evaluation and re-certification has been completed

• high product related risk e.g. based on design, materials, components, No

invasiveness, clinical procedures

• high risk anatomical locations No

• high risk target populations e.g. paediatrics, elderly Yes

• severity of disease/treatment challenges Yes

• questions of ability to generalize clinical investigation results No

• unanswered questions of long-term safety and performance No

• results from any previous clinical investigation, including adverse events or from No
post-market surveillance activities

• identification of previously unstudied subpopulations which may show different No

benefit/risk-ratio e.g. hip implants in different ethnic populations

• continued validation in cases of discrepancy between reasonable premarket No

follow-up time scales and the expected life of the product

• risks identified from the literature or other data sources for similar marketed No
devices

• interaction with other medical products or treatments No

• verification of safety and performance of device when exposed to a larger and No

more varied population of clinical users

• emergence of new information on safety or performance No

• where CE marking was based on equivalence* No

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It has been determined that the long-term clinical data demonstrate acceptable safety and
performance for the DeVilbiss oxygen concentrator’s (models 525 and 306) intended use. No
additional hazards or complications related to these devices were identified in this Clinical Evaluation
Report that have not been considered in the risk documentation or Instruction Guides.
Therefore, DeVilbiss does not believe post-market clinical follow-up is required to support the safety
and performance of the oxygen concentrators (models 525 and 306) for their stated indications. The
need for additional post-market clinical follow-up will continue to be evaluated as part of the clinical
evaluation process during post-market surveillance activities in accordance with MEDDEV 2.12.2
Rev. 2.

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8. Conclusions
The DeVilbiss Oxygen Concentrators models 525 and 306 have been in production since 2008 and
2009, respectively. This clinical evaluation has shown that both are acceptable for safety and
performance if used according to their respective Instruction Guides. The devices incorporate a full
range of desirable safety features. The Instruction Guides reflect current best use practices and
inform clinicians and patients of potential problems and hazards associated with the improper use of
these devices.
The articles retrieved in the literature search performed for this clinical evaluation and analysed in
section 6 suggest further improvements to the way assessments of portable pulse delivery devices
(such as DeVilbiss iGo Oxygen Concentrator model 306) are made by clinicians.
The iGo Oxygen Concentrator model 306 Instruction Guide does not contain a recommendation about
use of this device during sleep, but the website www.igopoc.com recommends the continuous flow
mode for use during sleep. This information would be conveyed to the patient by the prescribing
physician. Devices delivering constant pulse volume have not been tested in the sleep clinic.
Therefore DeVilbiss will add a statement to future editions of the Instruction Guide recommending
against the use of the device in pulse mode during sleep. It should be noted that the iGo unit will
automatically switch to continuous flow mode after 90 seconds if a breath is not detected.
The DeVilbiss Oxygen Concentrators (models 525 and 306) have been in production since
2008/2009. The overall complaints rate (complains per unit sold) over the period 1 January 2011 – 19
June 2015 was 3.4% for model 525 and 9.3% for model 306. Significantly, no adverse events or other
patient effects were noted in the complaints. Search of the FDA’s MAUDE database over the period 1
January 2011 to 1 March 2015 for reports of incidents associated with Respironics EverFlo (a device
equivalent to the DeVilbiss 5L Oxygen Concentrator) identified reports of patient deaths and injuries in
addition to device malfunctions. Smoking while using the device was a factor in some deaths and
injuries (a warning about this appears in the Instruction Guide for the DeVilbiss 5L Oxygen
Concentrator), but for most incidents a causative link to the device could not be definitively
established. Only eight malfunctions were reported for Respironics EverGo (a device equivalent to the
DeVilbiss iGo portable oxygen concentrator) over the same period of time.
It can be concluded that the clinical evidence appraised in this CER demonstrates conformity with the
relevant Essential Requirements of the MDD. The performance and safety of the devices as claimed
have been established. The devices are manufactured in such a way that when used under the
conditions and for the purposes intended, they will not compromise the clinical condition or the health
and safety of the user. The risks associated with the use of the devices are acceptable when weighed
against benefits to patients with chronic hypoxaemia requiring long term oxygen therapy.
No new hazards or complications related to DeVilbiss Oxygen Concentrators (models 525 and 306)
were identified in this Clinical Evaluation Report. Therefore, DeVilbiss does not believe post-market
clinical follow-up is required to support the safety and performance of these devices for their stated
indications. The need for additional post-market clinical follow-up will continue to be evaluated as part
of the clinical evaluation process during post-market surveillance activities in accordance with
MEDDEV 2.12.2 Rev. 2.
As part of post market surveillance review safety, performance, and the clinical benefit risk
assessment of the device will be performed and appropriate updates will be made to the clinical
evaluation.

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Appendix A: Literature Review Report

1. Device name/model: DeVilbiss 5 Liter Oxygen Concentrator (model 525) and iGo Portable
Oxygen System (model 306)
2. Scope of the literature search: A comprehensive search aimed at identifying all publications
relating to the safety and performance of DeVilbiss oxygen concentrators and equivalent devices
3. Methods
(i) Date of search: 30 July 2015 and 4 August 2015
(ii) Search performed by: Beata Wilkinson
(iii) Period of search: 2005 - current
(iv) Literature sources used to identify data: Search performed on PubMed.
PubMed is a service of the US National Library of Medicine® that:
• Provides free access to MEDLINE®, the NLM® database of indexed citations and abstracts
to medical, nursing, dental, veterinary, health care, and preclinical sciences journal articles
• Includes additional selected life sciences journals not in MEDLINE
• Adds new citations daily
• Was developed by the National Center for Biotechnology Information (NCBI) at the National
Library of Medicine (NLM)
(v) Database search - details in Appendix B
(vi) Selection criteria used to choose articles:
Selection criteria used to choose articles were established prior to abstract review.
Articles were selected for inclusion if they met all of the following criteria:
• Included devices of interest or equivalent devices
• Article provided enough information to evaluate the safety and performance of the
applicable product
• Human research
• English language
• Clinical Trial, Comparative Study, Case Reports
4. Outputs
(i) Copy of literature citations retrieved from each database search - listed in Appendix C
(ii) Data selection process - All citations were assessed for suitability for inclusion in the clinical
evaluation - details in Appendix D.

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Appendix B: Search of keywords

Advanced searches performed in PubMed:
Search #1
Search: (((oxygen) AND (concentrator OR "concentration system" OR "concentrating system" OR
generator OR "generation system" OR "generating system")) AND patient) NOT monoxide Filters:
Clinical Trial, Case Reports, Comparative Study, From 1995/01/01 to 2015/07/31, Humans, English
Results: 48
Search #2
Search: "iGo" Filters: Case Reports, Clinical Trial, Comparative Study, 5 years, Humans
Results: 9

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Appendix C: 1st level of selection: excluded articles

Exclusion Code Exclusion Criteria

E1 Not featuring oxygen concentrator(s)

E2 Unspecified oxygen concentrator(s)

E3 Not addressing safety or performance of oxygen concentrator(s)

E4 Oxygen concentrator(s) for different target population or use than the device under evaluation

Search #1 Results: 48

Author(s) Date Title Journal Exclusion

reason

Abernethy AP, McDonald CF, Frith PA, 2010 Effect of palliative oxygen versus Lancet. 2010 Sep 4;376(9743):784-93. E2
Clark K, Herndon JE 2nd, Marcello J, room air in relief of breathlessness
Young IH, Bull J, Wilcock A, Booth S, in patients with refractory
Wheeler JL, Tulsky JA, Crockett AJ, dyspnoea: a double-blind,
Currow DC. randomised controlled trial.

Akerø A, Edvardsen A, Christensen CC, 2011 COPD and air travel: oxygen Chest. 2011 Jul;140(1):84-90. E2
Owe JO, Ryg M, Skjønsberg OH. equipment and preflight titration of

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supplemental oxygen.

Andersson A, Ström K, Brodin H, Alton 1998 Domiciliary liquid oxygen versus Eur Respir J. 1998 Dec;12(6):1284-9. E3
M, Boman G, Jakobsson P, Lindberg A, concentrator treatment in chronic
Uddenfeldt M, Walter H, Levin LA. hypoxaemia: a cost-utility analysis.

Biedunkiewicz B, Tylicki L, Rachon D, 2004 Natural killer cell activity unaffected Int J Artif Organs. 2004 Sep;27(9):766-71. E1
Hak L, Nieweglowski T, Chamienia A, by ozonated autohemotherapy in
Debska-Slizien A, Mysliwska J, patients with end-stage renal
Rutkowski B. disease on maintenance renal
replacement therapy.

Bolton CE, Annandale JA, Ebden P. 2006 Comparison of an oxygen Chron Respir Dis. 2006;3(1):49-51. Include
concentrator and wall oxygen in the
assessment of patients undergoing
long term oxygen therapy
assessment.

Borggrefe MM, Lawo T, Butter C, 2008 Randomized, double blind study of Eur Heart J. 2008 Apr;29(8):1019-28. doi: E1
Schmidinger H, Lunati M, Pieske B, non-excitatory, cardiac contractility 10.1093/eurheartj/ehn020. Epub 2008 Feb 12.
Misier AR, Curnis A, Böcker D, Remppis modulation electrical impulses for
A, Kautzner J, Stühlinger M, Leclerq C, symptomatic heart failure.
Táborsky M, Frigerio M, Parides M,
Burkhoff D, Hindricks G.

Burioka N, Takano K, Suyama H, Chikumi 1997 Efficacy of newly developed Intern Med. 1997 Dec;36(12):861-4. E1
H, Hoshino E, Sasaki T. pressure swing adsorption type
oxygen concentrator with

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membrane humidifier: comparison

with conventional oxygen
concentrator with bubble water
humidifier.

Butter C, Wellnhofer E, Schlegl M, 2007 Enhanced inotropic state of the J Card Fail. 2007 Mar;13(2):137-42. E1
Winbeck G, Fleck E, Sabbah HN. failing left ventricle by cardiac
contractility modulation electrical
signals is not associated with
increased myocardial oxygen
consumption.

Campbell AJ, Ferrier K, Neill AM. 2012 Effect of oxygen versus adaptive Intern Med J. 2012 Oct;42(10):1130-6. E2
pressure support servo-ventilation
in patients with central sleep
apnoea-Cheyne Stokes respiration
and congestive heart failure.

Chatburn RL, Lewarski JS, McCoy RW. 2006 Nocturnal oxygenation using a Respir Care. 2006 Mar;51(3):252-6. Include
pulsed-dose oxygen-conserving
device compared to continuous
flow.

Cullen DL, Koss JA. 2005 Oxygen tubing lengths and output Chron Respir Dis. 2005;2(4):193-7. E1
flows: implications for patient care.

Das SK, Das S. 1995 Study of clinical anaesthesia with J Indian Med Assoc. 1995 Oct;93(10):377-9. E1
pedius A anaesthesia system using

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ketamine or halothane with muscle

relaxant.

De Ridder D, Vanneste S, Van Laere K, 2013 Chasing map plasticity in World Neurosurg. 2013 Dec;80(6):901. E1
Menovsky T. neuropathic pain.

Dogra G, Ward N, Croft KD, Mori TA, 2001 Oxidant stress in nephrotic Nephrol Dial Transplant. 2001 Aug;16(8):1626- E1
Barrett PH, Herrmann SE, Irish AB, syndrome: comparison of F(2)- 30.
Watts GF. isoprostanes and plasma
antioxidant potential.

Fauroux B, Boulé M, Lofaso F, Zérah F, 1999 Chest physiotherapy in cystic Pediatrics. 1999 Mar;103(3):E32. E1
Clément A, Harf A, Isabey D. fibrosis: improved tolerance with
nasal pressure support ventilation.

Gierula J, Cubbon RM, Jamil HA, Byrom 2013 Cardiac resynchronization therapy Europace. 2013 Nov;15(11):1609-14. doi: E1
R, Baxter PD, Pavitt S, Gilthorpe MS, in pacemaker-dependent patients 10.1093/europace/eut148. Epub 2013 Jun 4.
Hewison J, Kearney MT, Witte KK. with left ventricular dysfunction.

Grianti F, Montecchia F, Di Bari L, 1996 A versatile mechanical ventilator IEEE Trans Biomed Eng. 1996 E1
Baldassarri M. (DIGIT) with high flow stability and a Nov;43(11):1062-72.
programmable inspiratory phase
flow pattern.

Grossebner M, Arifi A, Bourov Y, Taylor 1999 No change in O2 saturation but Eur J Cardiothorac Surg. 1999 Aug;16(2):160 E1
G, Gray S, Ritchie A. measurable difference in thenar
flexor power after radial artery
harvest.

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Herrero P, Hartman JJ, Green MA, 1996 Regional myocardial perfusion J Nucl Med. 1996 Aug;37(8):1294-300. E1
Anderson CJ, Welch MJ, Markham J, assessed with generator-produced
Bergmann SR. copper-62-PTSM and PET.

Jackson M, Shneerson J. 1998 An evaluation of the use of Respir Med. 1998 Feb;92(2):250-5. E3
concentrators for domiciliary
oxygen supply for less than 8 h day-
1.

Jansson S, Lie-Karlsen K, Stenqvist O, 2001 Oxygen consumption in patients Ann Surg. 2001 Jan;233(1):60-4. E1
Körner U, Lundholm K, Tisell LE. with hyperthyroidism before and
after treatment with beta-blockade
versus thyrostatic treatment: a
prospective randomized study.

Katsenos S, Charisis A, Daskalopoulos G, 2006 Long-term oxygen therapy in Respiration. 2006;73(6):777-82. Epub 2006 Jun E2
Constantopoulos SH, Vassiliou MP. chronic obstructive pulmonary 30.
disease: the use of concentrators
and liquid oxygen systems in north-
western Greece.

Khaing TT, Yu S, Brock-Utne JG. 1997 Inspired oxygen concentrations with Anaesth Intensive Care. 1997 Aug;25(4):417-9. E4
or without an oxygen economizer
during ether draw-over
anaesthesia.

Khairy P, Landzberg MJ, Gatzoulis MA, 2006 Transvenous pacing leads and Circulation. 2006 May 23;113(20):2391-7. E1
Mercier LA, Fernandes SM, Côté JM, systemic thromboemboli in patients

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Lavoie JP, Fournier A, Guerra PG, with intracardiac shunts: a Epub 2006 May 15.
Frogoudaki A, Walsh EP, Dore A; multicenter study.
Epicardial Versus ENdocardial pacing
and Thromboembolic events
Investigators.

Ko D, Heck C, Grafton S, Apuzzo ML, 1996 Vagus nerve stimulation activates Neurosurgery. 1996 Aug;39(2):426-30; E1
Couldwell WT, Chen T, Day JD, Zelman central nervous system structures in discussion 430-1.
V, Smith T, DeGiorgio CM. epileptic patients during PET
H2(15)O blood flow imaging.

Kuroda M, Kawamoto M, Yuge O. 2005 Undisrupted pulse wave on pulse J Anesth. 2005;19(2):164-6. E1
oximeter display monitor at cardiac
arrest in a surgical patient.

Lacasse Y, Lecours R, Pelletier C, Bégin 2005 Randomised trial of ambulatory Eur Respir J. 2005 Jun;25(6):1032-8. E2
R, Maltais F. oxygen in oxygen-dependent COPD.

Lobato SD, Rodríguez EP, Alises SM. 2011 Portable pulse-dose oxygen Respir Care. 2011 Dec;56(12):1950-2. Include
concentrators should not be used
with noninvasive ventilation.

MacLeod JB, Gravelin S, Jones T, Gololov 2009 Assessment of acute trauma care Am Surg. 2009 Nov;75(11):1118-23. E3
A, Thomas M, Omondi B, Bukusi E. training in Kenya.

Milési C, Matecki S, Jaber S, Mura T, 2013 6 cmH2O continuous positive Pediatr Pulmonol. 2013 Jan;48(1):45-51. doi: E1
Jacquot A, Pidoux O, Chautemps N, airway pressure versus 10.1002/ppul.22533. Epub 2012 Mar 19.
Novais AR, Combes C, Picaud JC, conventional oxygen therapy in

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Cambonie G. severe viral bronchiolitis: a

randomized trial.

Moll JR, Vieira JE, Gozzani JL, Mathias 2014 Oxygen concentrators performance Braz J Anesthesiol. 2014 May-Jun;64(3):164-8. E4
LA. with nitrous oxide at 50:50 volume. doi: 10.1016/j.bjane.2013.06.011. Epub 2013
Oct 11.

Mwenge GB, Rombaux P, Dury M, 2013 Targeted hypoglossal Eur Respir J. 2013 Feb;41(2):360-7. doi: E1
Lengelé B, Rodenstein D. neurostimulation for obstructive 10.1183/09031936.00042412. Epub 2012 May
sleep apnoea: a 1-year pilot study. 17.

Nasilowski J, Przybylowski T, Zielinski J, 2008 Comparing supplementary oxygen Respir Med. 2008 Jul;102(7):1021-5. doi: Include
Chazan R. benefits from a portable oxygen 10.1016/j.rmed.2008.02.005. Epub 2008 Mar
concentrator and a liquid oxygen 21.
portable device during a walk test in
COPD patients on long-term oxygen
therapy.

Nonoyama ML, Brooks D, Guyatt GH, 2008 Ambulatory gas usage in patients J Cardiopulm Rehabil Prev. 2008 Sep- E2
Goldstein RS. with chronic obstructive pulmonary Oct;28(5):323-9. doi:
disease and exertional hypoxemia. 10.1097/01.HCR.0000336144.79192.5e.

Page E, Defaye P, Bonnet JL, Durand C, 2003 Comparison of the cardiopulmonary Pacing Clin Electrophysiol. 2003 Jan;26(1 Pt E1
Amblard A. response to exercise in recipients of 2):239-43.
dual sensor DDDR pacemakers
Versus a Healthy control group.

Petrakis E, Sciacca V. 2000 Prospective study of Int Angiol. 2000 Mar;19(1):18-25. E1

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transcutaneous oxygen tension

(TcPO2) measurement in the testing
period of spinal cord stimulation in
diabetic patients with critical lower
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Ringbaek T, Martinez G, Lange P. 2013 The long-term effect of ambulatory Chron Respir Dis. 2013 May;10(2):77-84. E4
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patients: a randomised study.

Rodriquez D Jr, Blakeman TC, Dorlac W, 2010 Maximizing oxygen delivery during J Trauma. 2010 Jul;69 Suppl 1:S87-93. doi: E4
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Sofic E, Sapcanin A, Tahirovic I, 2006 Antioxidant capacity in postmortem J Neural Transm Suppl. 2006;(71):39-43. E1
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Grether-Beck S, Klotz LO, Tsuji T, versus nonmalignant human T cells
Krutmann J. toward ultraviolet A-1 radiation-
induced apoptosis.

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Zygun DA, Nortje J, Hutchinson PJ, 2009 The effect of red blood cell Crit Care Med. 2009 Mar;37(3):1074-8. doi: E1
Timofeev I, Menon DK, Gupta AK. transfusion on cerebral oxygenation 10.1097/CCM.0b013e318194ad22.
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Center Study Group.

Meyers KJ, Mares JA, Igo RP Jr, Truitt B, Liu Z, 2014 Genetic evidence for role of Invest Ophthalmol Vis Sci. 2014 Jan E1
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Rajagopalan S, Ryan T, Igo SR, Jackson MS, mitral regurgitation by automated 3- 1;6(1):125-33. doi:
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G, Kemp JP, Pourcain BS, Simpson CL, Mäkelä
KM, Lehtimäki T, Kähönen M, Paterson AD,

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Hosseini SM, Wong HS, Xu L, Jonas JB,

Pärssinen O, Wedenoja J, Yip SP, Ho DW, Pang
CP, Chen LJ, Burdon KP, Craig JE, Klein BE,
Klein R, Haller T, Metspalu A, Khor CC, Tai ES,
Aung T, Vithana E, Tay WT, Barathi VA;
Consortium for Refractive Error and Myopia
(CREAM), Chen P, Li R, Liao J, Zheng Y, Ong RT,
Döring A; Diabetes Control and Complications
Trial/Epidemiology of Diabetes Interventions
and Complications (DCCT/EDIC) Research
Group, Evans DM, Timpson NJ, Verkerk AJ,
Meitinger T, Raitakari O, Hawthorne F,
Spector TD, Karssen LC, Pirastu M, Murgia F,
Ang W; Wellcome Trust Case Control
Consortium 2 (WTCCC2), Mishra A,
Montgomery GW, Pennell CE, Cumberland
PM, Cotlarciuc I, Mitchell P, Wang JJ, Schache
M, Janmahasatian S, Igo RP Jr, Lass JH, Chew
E, Iyengar SK; Fuchs' Genetics Multi-Center
Study Group, Gorgels TG, Rudan I, Hayward C,
Wright AF, Polasek O, Vatavuk Z, Wilson JF,
Fleck B, Zeller T, Mirshahi A, Müller C,
Uitterlinden AG, Rivadeneira F, Vingerling JR,
Hofman A, Oostra BA, Amin N, Bergen AA, Teo
YY, Rahi JS, Vitart V, Williams C, Baird PN,
Wong TY, Oexle K, Pfeiffer N, Mackey DA,

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Young TL, van Duijn CM, Saw SM, Bailey-

Wilson JE, Stambolian D, Klaver CC, Hammond
CJ.

Zhang X, Igo RP Jr, Fondran J, Mootha VV, 2013 Association of smoking and other risk Invest Ophthalmol Vis Sci. 2013 Aug E1
Oliva M, Hammersmith K, Sugar A, Lass JH, factors with Fuchs' endothelial corneal 27;54(8):5829-35.
Iyengar SK; Fuchs' Genetics Multi-Center dystrophy severity and corneal
Study Group. thickness.

In addition, an article provided by DeVilbiss, (Johns et al., 1985) was included in 2nd level of selection.

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Appendix D: 2nd level of selection: included and excluded articles

Author/ Clinical results: Criteria for Oxford level of Comments Included:

Date suitability evidence (optional) Yes/No
Safety, performance and equivalence
/ Ref (mandatory)

CE Bolton, JA • Description of the study: D2 A1 P1 R1 Level 2 Yes

Annandale and
P Ebden Cross-over design study using both
(2006) piped wall oxygen and an oxygen
Comparison Of concentrator.
An Oxygen
Concentrator • Number of patients :
And Wall
Oxygen In The 10 ( adult)
Assessment Of
Patients • Follow-up :
Undergoing
Long Term NA
Oxygen
Therapy
• Procedure :
Assessment. After 30 minutes of rest, the patient
Chronic was started on either piped wall
Respiratory oxygen or an oxygen concentrator for
Disease 3: (pp 30 minutes at 2L/minute via nasal
49-51)
speculae. After 30 minutes, an arterial
blood gas (ABG) was taken and
analysed immediately. The oxygen
delivery method was then switched.
Another ABG was taken. The patient
was returned to the original oxygen
source for 30 minutes. The final ABG
was taken.
• Device Name :

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Piped wall oxygen or Puritan Bennett

Companion 492a

● Safety: description and relevance

NA

● Performance: description and relevance

PaO2 was significantly lower in patients who
received oxygen via an oxygen concentrator
than those who received oxygen via piped wall
oxygen.
The oxygen concentration delivered by the study
concentrator was 93% on both occasions it was
tested.

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D) Device: D1 (actual device), D2 (equivalent device), D3 (other device)

I) Application/ Intended use: A1 (same use), A2 (minor deviation), A3 (deviation)
P) Patient group: P1 (applicable), P2 (limited), P3 (different population)
R) Report/data collation: R1 (high quality), R2 (minor deficiencies), R3 (insufficient information)
Criteria for data contribution: Oxford level of evidence (March 2011), report to appendix F
NA: not applicable

Author/ Clinical results: Criteria for Oxford level of Comments Included:

Date suitability evidence (optional) Yes/No
Safety, performance and equivalence
/ Ref (mandatory)

Robert L • Description of the study: D3 A1 P1 R1 Level 2 Yes

Chatburn RRT- The Inogen One provided the
NPS FAARC, This study compared the heart rate and same clinical benefit as a (significance
Joseph S oxygen saturation of sleeping patients continuous-flow nasal cannula of the
Lewarski RRT receiving oxygen via a pulsed dose in 90% of a small sample of different
FAARC, and
oxygen conserving device (PDOCD) or patients during sleep. modes of
Robert W
McCoy RRT continuous flow oxygen. Each patient The authors attributed this to oxygen pulse
FAARC (2006) acted as their own control. the “fixed minute volume” mode delivery)
of operation. The result cannot
Nocturnal • Number of patients : 10 (adults) be extrapolated to devices
Oxygenation
Using a • Follow-up :NA utilizing “uniform pulse” (such
Pulsed-Dose as iGo)
Oxygen- • Procedure :

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Conserving Each patient was switched from

Device continuous flow oxygen to pulsed dose
Compared to
Continuous
oxygen. The pulsed dose oxygen was
Flow adjusted to produce an SpO2 equal to
the SpO2 on continuous flow. The
Respiratory
mean PDOCD setting was 3 (range1-5)
Care 51(3)
252-256 • Device Name :
Inogen One, (Inogen, Goleta,
California)

● Safety: description and relevance

One patient in the default (lower)
sensitivity group experienced a clinically
important lowerSpO2 with the PDOCD
than with continuous-flow (86% vs
97%), and the oxygen concentrator data
log suggested that he frequently failed
to trigger the PDOCD throughout the
sleep period. Note: No device
adjustments were performed during the
single-night sleep study. In actual
clinical practice this situation could be
remedied by increasing the oxygen
sensitivity and setting during sleep.
● Performance: description and relevance
Patients slept an average of 1 hour
more when using the PDOCD than
continuous flow.
There was a statistically significant but
clinically unimportant difference in SpO2
between continuous flow and PDOCD

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(95.7% vs 93.2%, p = 0.043).

For the subset of patients whose
PDOCD was set on sensitive, there was
a statistically significant but clinically
unimportant difference in SpO2
(continuous-flow 95.6% vs PDOCD
93.2%, p=0.044).

No difference in heart rate was

detected.

D) Device: D1 (actual device), D2 (equivalent device), D3 (other device)

I) Application/ Intended use: A1 (same use), A2 (minor deviation), A3 (deviation)
P) Patient group: P1 (applicable), P2 (limited), P3 (different population)
R) Report/data collation: R1 (high quality), R2 (minor deficiencies), R3 (insufficient information)
Criteria for data contribution: Oxford level of evidence (March 2011), report to appendix F
NA: not applicable

Author/ Clinical results: Criteria for Oxford level of Comments Included:

Date suitability evidence (optional) Yes/No
Safety, performance and equivalence
/ Ref (mandatory)

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C.LeBlanc, • Description of the study: D1 A1 P1 R1 Level 2 Bolus size can be an important Yes
L.Lavallee, factor in determining the
J.King, et al Comparison of the ability of 3 portable
(2013) A
effectiveness of a POC.
oxygen concentrators to maintain Lifestyle factors should be
Comparative SpO2 ≥ 90% during exercise
Study of 3 taken in consideration in
Portable • Number of patients : choosing a POC system.
Oxygen
Concentrators 21 ( adult)
During a 6-
Minute Walk • Follow-up :
Test in
Patients With NA
Chronic Lung
Disease
• Procedure : Four 6-minute walking tests
were performed. First test used the
Respiratory current oxygen system and prescribed
Care 58(10)
exertional flow rate. The remaining
pp 1598-1605
tests used each of the portable oxygen
concentrators at their maximum pulse-
dose setting.
• Device Name :
EverGo (Respironics, Murrysville,
Pennsylvania),
iGo (DeVilbiss Healthcare, Summerset,
Pennsylvania),
Eclipse 3 (Caire Medical, Ball Ground,
Georgia).

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● Safety: description and relevance

N/A

● Performance: description and relevance

The SpO2 was significantly higher pre-
walk and post-walk with the Eclipse 3,
compared to the other POCs (all P <
.01).
The subjects also walked farther and
maintained a mean SpO2 > 90% with
the Eclipse 3 (both P < .01), which
delivers the largest oxygen bolus.
The subjects indicated that they
preferred the EverGo’s physical
characteristics, but that the Eclipse 3
responded best to their breathing.
The iGo was rated less favorably than
Eclipse 3 or EverGo during preference
testing.

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D) Device: D1 (actual device), D2 (equivalent device), D3 (other device)

I) Application/ Intended use: A1 (same use), A2 (minor deviation), A3 (deviation)
P) Patient group: P1 (applicable), P2 (limited), P3 (different population)
R) Report/data collation: R1 (high quality), R2 (minor deficiencies), R3 (insufficient information)
Criteria for data contribution: Oxford level of evidence (March 2011), report to appendix F
NA: not applicable

Author/ Clinical results: Criteria for Oxford level of Comments Included:

Date suitability evidence (optional) Yes/No
Safety, performance and equivalence
/ Ref (mandatory)

Salvador Díaz
Pulse-dose oxygen technology
• Description of the study: D3 A1 P1 R3 Level 4
generally works by detecting
Yes
Lobato PhD,
Esteban Pe´rez This is a case study report of one the patient’s inspiratory effort (in
Rodríguez patient who without a medical and triggering the delivery of a association
PhD, and recommendation, was using a portable bolus of oxygen in the first 100 with Chatburn
Sagrario
oxygen concentrator during nocturnal ms of the inspiration. The et al., 2006)
Mayoralas
Alises PhD non-invasive ventilation (NIV). oxygen flow then turns off until
(2011) the next inspiration is detected.
Portable • Number of patients : Like other portable oxygen
Pulse-Dose 1 (adult) concentrators, the Inogen One
Oxygen uses pressure sensing to
Concentrators • Follow-up :
Should Not Be
identify the onset of inspiration.
Used With N/A The Inogen One also monitors
Noninvasive the respiratory rate and adjusts
Ventilation. • Procedure : the bolus volume to maintain a
Respiratory Laboratory testing with the patient consistent minute volume of
Care using the concentrator and ventilator oxygen. The NIV inspiratory
56(12):1950- and expiratory pressures in the
was conducted.
1952 ventilator circuit prevented the
• Device Name : Inogen One from identifying the
onset of inspiration, so the

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Inogen One, (Inogen, Goleta, concentrator simply did not

California) work as it is supposed to.

● Safety: description and relevance

N/A
● Performance: description and relevance
The concentrator did not detect the
patient’s inspiratory effort or deliver the
preset oxygen flow at any of the tested
settings.

D) Device: D1 (actual device), D2 (equivalent device), D3 (other device)

I) Application/ Intended use: A1 (same use), A2 (minor deviation), A3 (deviation)
P) Patient group: P1 (applicable), P2 (limited), P3 (different population)
R) Report/data collation: R1 (high quality), R2 (minor deficiencies), R3 (insufficient information)
Criteria for data contribution: Oxford level of evidence (March 2011), report to appendix F
NA: not applicable

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Author/ Clinical results: Criteria for Oxford level of Comments Included:

Date suitability evidence (optional) Yes/No
Safety, performance and equivalence
/ Ref (mandatory)

JR Moll, JE
Concentrators connected to
• Description of the study: D2 A3 P3 R1 Level 2
medical gas pipeline systems
No
Vieira, JL or
Gozzani et al Comparison study of surgical patients D3 can be considered a stable (not a listed
(2013) receiving either oxygen from source of oxygen for use during indication for
Oxygen concentrators or oxygen from short anesthetic procedures, DeVilbiss 5L
Concentrators concentrators plus nitrous oxide. either pure or in association oxygen
Performance with nitrous oxide at 50:50 concentrator)
With Nitrous • Number of patients : 60 (adults) volume.
Oxide At 50:50
Volume • Follow-up :
Brazilian N/A
Society of
Anesthesiolog • Procedure :
y 64(3):164-
168
Adult patients were randomly allocated
into two groups, receiving a fresh gas
flow of oxygen from concentrators
(O293) or of oxygen from
concentrators and nitrous oxide
(O293N2O). The fraction of inspired
oxygen and the percentage of oxygen
from fresh gas flow were measured
every 10 min. The ratio of FiO2/oxygen
concentration delivered was compared
at various time intervals and between
the groups
• Device Name : 0293

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● Safety: description and relevance

N/A
● Performance: description and relevance
There was no difference in oxygen from
concentrators over time for both groups,
but there was a significant improvement
in the FiO2 (p < 0.001) for O293 group
while a significant decline (p < 0.001) for
O293N2O.

The FiO2/oxygen ratio varied in both

groups, reaching a plateau in the O293
group.

Pulse oximetry did not fall below 98.5%

in either group.

D) Device: D1 (actual device), D2 (equivalent device), D3 (other device)

I) Application/ Intended use: A1 (same use), A2 (minor deviation), A3 (deviation)
P) Patient group: P1 (applicable), P2 (limited), P3 (different population)
R) Report/data collation: R1 (high quality), R2 (minor deficiencies), R3 (insufficient information)
Criteria for data contribution: Oxford level of evidence (March 2011), report to appendix F
NA: not applicable

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Author/ Clinical results: Criteria for Oxford level of Comments Included:

Date suitability evidence (optional) Yes/No
Safety, performance and equivalence
/ Ref (mandatory)

J Nasilowski, T • Description of the study: D2 A1 P1 R1 Level 2 POCs may be safely used for Yes
Przybylowski, J ambulatory oxygen treatment.
Zielinski et al Randomized, single-blind clinical trial to
(2008) determine if oxygen from a portable
Comparing oxygen concentrator (POC) is as
Supplementary effective as piped wall oxygen (LO) in
Oxygen reducing exercise-induced hypoxaemia
Benefits From A in severe COPD patients on LTOT.
Portable
Oxygen • Number of patients : 13 ( adult)
Concentrator
And A Liquid • Follow-up :
Oxygen
Portable Device N/A
During A Walk
Test In COPD • Procedure :
Patients On
Subjects underwent a series of five-6-
Long-Term
Oxygen minute walk tests (6 MWT). First 2
Therapy tests were considered training
sessions. Last 3 tests were performed
Respiratory
Medicine102:
with one of three tested devices
(pp 1021-1025)
•
• Device Name :
LifeStyle AirSep, (Buffalo, NY, USA),
LO cylinder (Taema, France)
Cylinder with compressed air (CA) .

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● Safety: description and relevance

N/A

● Performance: description and relevance

No statistically significant differences in
oxygenation between POC and
portable LO.
However, in order in order to prevent
hypoxaemia during strenuous exercise
the authors suggest that three-fold
increase of oxygen flow should be
prescribed.

D) Device: D1 (actual device), D2 (equivalent device), D3 (other device)

I) Application/ Intended use: A1 (same use), A2 (minor deviation), A3 (deviation)
P) Patient group: P1 (applicable), P2 (limited), P3 (different population)
R) Report/data collation: R1 (high quality), R2 (minor deficiencies), R3 (insufficient information)
Criteria for data contribution: Oxford level of evidence (March 2011), report to appendix F
NA: not applicable

Author/ Clinical results: Criteria for Oxford level of Comments Included:

Date suitability evidence (optional) Yes/No
Safety, performance and equivalence
/ Ref (mandatory)

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DP Johns, PD
The main disadvantage of
• Description of the study: D3 A1 P3 R1 N/A
concentrators compared with
Yes
Rochford and
JA Streeton Laboratory study comparing the cylinders is the possibility of (highlights
(1985) performance, safety and operation of machine failure or power desirable
Evaluation Of six oxygen concentrators. failure. However, this risk can safety feature
Six Oxygen be minimized if a stock of spare added in the
Concentrators • Number of patients : parts and a standby machine development
None – Laboratory Study centrally located are readily of DeVilbiss
available. 5L Oxygen
• Follow-up : Concentrator)
Thorax 40: (pp N/A
806-810)
• Procedure :
Six litres of gas was collected from
each concentrator in a rebreathing bag
for analysis.
•
• Device Name
DeVO 2 (Devilbiss Co, USA)
Dom 10 (RImer-Alco, UK)
Econo 2 (Mountain Medical Equipment,
USA)
Hudson 6200 (Ventronics, USA)
Permox (Dragerwerk, Germany)
Roomate (Cryogenic Associates, USA)

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● Safety: description and relevance

Spectral analysis was conducted on the gas
produced by the Hudson concentrator (only) and
showed oxygen, argon (3.6%) and nitrogen to
be the major components with oxygen and
argon approximately equal. Carbon dioxide was
detected in trace concentrations only.
● Performance: description and relevance
The oxygen concentration produced varied in a
cyclical manner in all models, especially at the
higher flow settings.
No significant changes in delivered flow of %O 2
were found when short (2m) and long (7-15 m)
delivery tubes were used.

D) Device: D1 (actual device), D2 (equivalent device), D3 (other device)

I) Application/ Intended use: A1 (same use), A2 (minor deviation), A3 (deviation)
P) Patient group: P1 (applicable), P2 (limited), P3 (different population)
R) Report/data collation: R1 (high quality), R2 (minor deficiencies), R3 (insufficient information)
Criteria for data contribution: Oxford level of evidence (March 2011), report to appendix F
NA: not applicable

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Appendix E: Criteria of suitability and Oxford level of evidence

Criteria of Suitability (According to MEDDEV2.7.1 Rev 3 (2009))

Suitability Criteria Description Grading System

Appropriate device Were the data generated from the device in question? D1 Actual device
D2 Equivalent device
D3 Other device

Appropriate device application Was the device used for the same intended use (e.g., methods of A1 Same use
deployment, application, etc.)?
A2 Minor deviation
A3 Major deviation

Appropriate patient group Where the data generated from a patient group that is representative of P1 Applicable
the intended treatment population e.g., age, sex, etc.) and clinical
P2 Limited
condition (i.e., disease, including state and severity)?
P3 Different population

Acceptable report/ data collection Do the reports or collations of data contain sufficient information to be able R1 High quality
to undertake a rational and objective assessment?
R2 Minor deficiencies
R3 Insufficient information

Criteria of Contribution: Oxford level of Evidence (March 2011)

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Appendix F: Search of clinical trial register (ie. Clinicaltrials.gov,

WHO…)
N/A
This is specific to completed trials that have results posted on a registry where the data has not been
available via publication.

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Appendix G: Complaint/ Incidence Report

Complaints to DeVilbiss
5 Liter Oxygen Concentrator (base model 525)

A total of 823 customer complaints were registered over the period 1 January 2012 – 19 June 2015.
The total number of unit sales was 23,996. The overall complaints rate for the 5 Liter Oxygen
Concentrator was therefore 3.43%. No patient effect was noted in the complaints.

The most frequently reported issues for the 5 Liter Oxygen Concentrator were sieve bed issues
(23.0%), compressor issues (15.8%), non-specific issues (13.0%), tubing issues (7.3%) and exhaust
muffler or silencer issue (5.6%). The remaining 21 complaint categories were reported at a rate of
<5.0% per category..

Summary of complaints registered for the 5 Liter Oxygen Concentrator over the period 1 January
2012 – 19 June 2015:

Complaint category Brief Description # of Complaints (%)

SB01, SB02, SB04, SB05 Sieve bed issue 189 23.0%
MT01, MT02, MT05, MT09, MT13, Compressor issue 130 15.8%
MT15, MT18, MT26, MT31, MT32,
MT49, MT50, MT59, MT62, MT63
MS05. MS14, MS17 Non-specific issue 107 13.0%
BD06, BD012, BD015, BD016, BD17, Board (main, mother or 87
BD20 motor) issue 10.6%
TB03, TB04, TB05 Tubing issue 60 7.3%
ES01, ES02 Exhaust muffler or 46
silencer issue 5.6%
VA06, VA07, VA16, VA19, VA24, Valve issue 31
VA25, VA34 3.8%
IC01, IC02, IC03 Intake canister issue 26 3.2%
WH03, WH06, WH08 Wiring Issue 24 2.9%
CP02, CP03, CP04, CP05, CP23, Capacitor issue 18
CP28, CP58 2.2%
FA02, FA03 Fan issue 14 1.7%
FG11, FG12, FG13 Outlet port issue 14 1.7%
FM01, FM04 Flow meter issue 13 1.6%
FT03, FT04, FT05, FT07 Filter issue 12 1.5%
OR01 O 2 port issue 11 1.3%
CK01 Check valve issue 7 0.9%
FG03, FG08 Fitting issue 6 0.7%
PK Packaging Material 6 0.7%
CA06, CA07 Bib issue 4 0.5%
FS02, FS06, FS11, FS12 Clamp issue 4 0.5%
LC10, LC12 Line cord issue 3 0.4%
WE01, WE02 Wheel issue 3 0.4%
MM01, MM05 Motor issue 2 0.2%
CP58 Piezo defective 2 0.2%
RG01, RG11 Regulator issue 2 0.2%

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Complaint category Brief Description # of Complaints (%)

CP34 Switch issue 1 0.1%
RB01 Component for refurb 1 0.1%
CAPAs and recalls
There were no CAPAs or recalls on the 5 Liter Oxygen Concentrator during the period 1 January
2012 – 19 June 2015.

Analysis of the search of the MAUDE database

There were no records identified involving the 5 Liter Oxygen Concentrator during the period 1
January 2012 – 19 June 2015.

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iGo Portable Oxygen Concentrator (base model 306)

A total of 190 customer complaints were registered over the period 1 January 2012 – 19 June 2015.
The total number of unit sales was 2,034. The overall complaints rate for the iGo Portable Oxygen
Concentrator was therefore 9.34%. No patient effect was noted in the complaints.

The most frequently reported issues for the iGo Portable Oxygen Concentrator were key pad issues
(32.6%), valve issues (17.4 %), sieve bed issues (14.2%), motor issues (8.9%), and non-specific
issue (7.9%). The remaining 10 complaint categories were reported at a rate of <5.0% per category.

Summary of complaints registered for the iGo Portable Oxygen Concentrator over the period 1
January 2012 – 19 June 2015:

Complaint category Brief Description # of Complaints (%)

Keypad defective or not
KP01, KP03 62
connected 32.6%
VA01, VA02, VA03, VA05, VA06, Valve issue
33
VA07, VA16 17.4%
SB01, SB02 Sieve bed issue 27 14.2%
MT03, MT04, MT05, MT08, MT26, Motor issue
17
MT50 8.9%
MS05 Non-specific issue 15 7.9%
WH04, WH06, WH09, WH11 Wiring issue 9 4.7%
Board (main, mother or
BD05, BD06, BD07, BD08, BD15 8
motor) issue 4.2%
AD08,AD11, AD13 Car adaptor issue 4 2.1%
BA06, BA11 Battery issue 3 1.6%
FA03, FA04 Fan issue 3 1.6%
FG12 Outlet port issue 3 1.6%
MS10 Unit vibration issue 2 1.1%
TB03, TB01 Tubing issue 2 1.1%
CP34 Switch issue 1 0.5%
RG03 Regulator leaking 1 0.5%

CAPAs and recalls

There were no CAPAs or recalls on the iGo Portable Oxygen Concentrator during the period 1
January 2012 – 19 June 2015.

Analysis of the search of the MAUDE database

There were no records identified involving the iGo Portable Oxygen Concentrator during the period 1
January 2012 – 19 June 2015.

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Search of the FDA’s MAUDE database 1 Jan 2012– 19 Jun 2015

The database was searched by manufacturer and brand name. Terms searched:
• “Respironics” and “EverFlo” and “EverGo”
• “DeVilbiss” and “iGo” and “5L Concentrator”

No records were identified for either of the DeVilbiss’ devices. Seventy three records were identified
for EverFlo and eight records were identified for EverGo. The search results are presented in tabular
format in Table 1.

Table 4 MAUDE Search results

Manufacturer/ Respironics/ Respironics/ DeVilbiss/ DeVilbiss/

Brand Name EverFlo EverGo iGo 5L Concentrator
# of Records
73 8 0 0
Returned
Of the seventy three records identified for EverFlo, 3 records described the same event and 1 record
described an event that occurred outside of the specified timeframe. These records were removed
from consideration leaving a total of 70 records for analysis. A breakdown of the reported events for
each device, according to the categories of ‘Deaths’, ‘Injury’ or ‘Malfunction’ is presented in Table 2.
Table 5 Event Breakdown

Manufacturer/Brand Name Deaths Injury Malfunction Total

Records
Analyzed
Respironics/EverFlo
11 39 20 70

Respironics/ EverGo 0 6 2 8

Of the eight records identified for EverGo, two records described device malfunctions that did not
result in patient injury and six records described events that did result in patient injury. A detailed
analysis of EverGo events is presented in Table 3.

Table 6 EVERGO MAUDE Events

Manufacturer Product Event Date Description Event Type Failure
Mode

RESPIRONICS, EVERGO 10/22/2014 Patient complaint of low Injury Leaking

INC oxygen output. Patient compressor
was hospitalized but has
since been released.
Health care provider noted
patient has other health
issues which may have
contributed to the

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Manufacturer Product Event Date Description Event Type Failure

Mode
hospitalization.
Complaint confirmed by
the manufacturer. Device
evaluation revealed a
leaking compressor.

RESPIRONICS, EVERGO 12/16/2013 Patient complained of an Injury Odor

INC odor from the
concentrator which caused
the patient to suffer
smoke inhalation and a
subsequent infection
which required the patient
to be treated with
antibiotics. A third party
service center evaluated
the device and was not
able to confirm the odor.
Furthermore, the device
was found to operate
according to design
specifications.

RESPIRONICS, EVERGO 02/18/2014 Patient suffered a heart Injury Not

INC attack and brain damage Specified
while using the device. The (NS)
device was not returned to
the manufacturer for
evaluation.

RESPIRONICS, EVERGO 11/28/2012 Healthcare professional Injury Low

INC reported a patient using Batteries
the device during air travel
had low blood oxygen
levels and was taken to the
hospital. The patient was
released the same day.
The manufacturer
evaluated the device and
found that the batteries
were depleted. The
batteries were charged
and the device passed all
functional testing.

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Manufacturer Product Event Date Description Event Type Failure

Mode

RESPIRONICS, EVERGO 10/15/2012 Patient received a burn Injury DC adapter

INC when removing the dc
adaptor from the car’s dc
outlet. The burn became
infected and the patient
required antibiotics. The
device was not returned to
the manufacturer for
evaluation.

RESPIRONICS, EVERGO 05/31/2012 A patient using the device Injury Not

INC had a low blood oxygen Specified
saturator and was (NS)
admitted to the hospital
for treatment. The device
was not returned to the
manufacturer for
evaluation.

RESPIRONICS, EVERGO 08/01/2014 Patient rented a POC for Malfunction Multiple

INC use during air travel and technical
away from home. The issues
patient experienced
multiple technical
problems. Patient returned
the first POC for another
(same make and model)
and continued to
experience multiple
technical problems.
Patient experienced panic
but no physical injuries.

RESPIRONICS, EVERGO 04/09/2013 A thermal event associated Malfunction Power cord

INC with the device’s power issue
cord occurred. No report
of patient injury or harm.
The device was not
returned to the
manufacturer for
evaluation.

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Considerably more records were returned for Respironics’ EverFlo device than for their EverGo
device. A detailed analyses of these events is present in Tables 4,5 and 6.

Although there were 11 deaths reported in conjunction with the use of the EverFlo device, no
definitive device involvement was determined. Smoking while using the device was found to be a
contributing factor in 2 of the deaths. Product labeling instructs the user not to smoke while using
the device. A detailed analysis of the reported deaths for the EverFlo device is presented in Table 4.

Table 7 EVERFLO – MAUDE Events - Deaths

Manufacturer Product Event Date Description Event Type Failure
Mode

RESPIRONICS, EVERFLO 2/12/2014 Patient died while using Death Not

INC the device. Device to be Specified
returned for evaluation. (NS)

RESPIRONICS, EVERFLO 12/3/2014 Power outage caused the Death Power

INC device to stop functioning. outage
Patient was unable to
utilize their back up oxygen
supply. Patient died.
Device not returned to
manufacturer for
evaluation.

RESPIRONICS, EVERFLO 12/7/2013 Device malfunctioned. Death NS

INC Patient suffered a brain
injury due to lack of oxygen
and died a few months
later. Device not returned
to manufacturer for
evaluation.

RESPIRONICS, EVERFLO 05/14/2014 Device malfunction and Death NS

INC patient died. Device not
returned for evaluation.

RESPIRONICS, EVERFLO 02/13/2014 Patient expired while using Death Smoking

INC the device. Pt was while using
smoking. No report of a the device
device malfunction. Patient
had been educated not to
smoke when using the
device. Device has yet to
be returned.

RESPIRONICS, EVERFLO 06/14/2013 Device involved in a fire. Death Fire

INC patient died the day after.
Device not yet returned for
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Manufacturer Product Event Date Description Event Type Failure

Mode
manufacturer evaluation.

RESPIRONICS, EVERFLO 04/18/2013 Patient expired while using Death NS

INC the device. Manufacturer
evaluation revealed no
malfunctions or
deficiencies. The device
was found to operate to
design specs.

RESPIRONICS, EVERFLO 04/04/2013 Patient expired while using Death NS

INC the device. Device not yet
returned for manufacturer
evaluation.

RESPIRONICS, EVERFLO 08/21/2012 Nasal cannula caught on Death Smoking

INC fire while connected to the while using
device and while the the device
patient was smoking. The
patient died.
Manufacture evaluation
confirmed product labeling
provides adequate warning
against using the device
while smoking.

RESPIRONICS, EVERFLO 02/17/2012 Patient expired while Death NS

INC concentrator was in use
with a ventilator. A yellow
light was illuminated. The
manufacturer could not
duplicate the malfunction
and found the device to
operate to design specs.
(Note: Device returned to
manufacturer for
evaluation 03/06/2012).

RESPIRONICS, EVERFLO 02/17/2012 Oxygen concentrator not Death NS

INC working while the patient
was not breathing. Family
member states device was
working prior to, and
following the event.

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Manufacturer Product Event Date Description Event Type Failure

Mode
Reason for use – chronic
respiratory failure and
neuromuscular weakness.
(Note: Device returned to
manufacturer for
evaluation 02/24/2012).

There were 23 reports of device malfunctions for Respironic’s EverFlo device. Upon further review
of the records, 3 reports involved patient injuries and were moved to the injury category leaving 20
device malfunctions for analysis. The most frequently reported malfunction involved power cord
issues (12). The remaining malfunctions were fire (4), smoking while using the device (3) and circuit
board issue (1). Of the 4 events involving ‘fire’, the device was returned to the manufacturer for
evaluation for 2 of the events. The manufacturer found that the device operated to design
specifications. The device was not returned for the other 2 events. Product labeling was evaluated
for the events that involved smoking while using the device and found to be sufficient as product
labeling does instructs the user not to smoke while using the device. A detailed analysis of the
reported malfunctions for the EverFlo device is presented in Table 5.

Table 8 EVERFLO – MAUDE Events – Malfunctions

Manufacturer Product Event Date Description Event Type Failure
Mode

RESPIRONICS, EVERFLO 03/22/2015 Nasal cannula caught on fire Malfunctio Smoking

INC from a lit cigarette. No n while
reports of patient harm or using the
injury. Manufacturer device
evaluation found thermal
damage caused by an
external source. Product
labeling warns against using
near open flames.

RESPIRONICS, EVERFLO 10/01/2013 Nasal cannula showed Malfunctio Smoking

INC evidence of thermal damage. n while
No reports of patient harm using the
or injury. The durable device
medical equipment supplier
suggested the patient’s
smoking could have been the
source of the fire. Product
labeling warns against
smoking when using the
concentrator.

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Manufacturer Product Event Date Description Event Type Failure

Mode

RESPIRONICS, EVERGO 01/25/2015 Device caught on fire while in Malfunctio Smoking

INC use. No reports of patient n while
injury or harm. Manufacturer using the
Follow-Up: Fire Marshall device
report stated the fire was
ignited by the patient
smoking. Manufacturer
concludes device did not
cause the fire. Product
labeling warns against
smoking while using the
device.

RESPIRONICS, EVERFLO 06/15/2012 Oxygen tubing caught on fire Malfunctio Fire

INC while in use. No reports of n
patient harm or injury.
Device not yet returned to
manufacturer for evaluation.

RESPIRONICS, EVERFLO 06/07/2015 Complaint that device caused Malfunctio Fire

INC a house fire. No reports of n
patient harm or injury.
Device evaluation by the
manufacturer revealed
device operated to design
specifications. Power cord
was replaced for cosmetic
reasons.

RESPIRONICS, EVERFLO 12/16/2014 Report that the device Malfunctio Fire

INC caught on fire while in use. n
No report of patient injury or
harm. Manufacture
evaluation found no
evidence of internal thermal
damage or any
manufacturing defect or
internal problem.

RESPIRONICS, EVERFLO 08/19/2012 Device caught on fire while in Malfunctio Fire

INC use. No reports of patient n
harm or injury. Device has
not yet been returned for
evaluation.

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Manufacturer Product Event Date Description Event Type Failure

Mode

RESPIRONICS, EVERFLO 03/09/2015 Thermal damage to the Malfunctio Power

INC power cord. No report of n cord
patient injury. issue

RESPIRONICS, EVERFLO 02/03/2015 Thermal damage to power Malfunctio Power

INC cord. No report of patient n cord
(3 records
injury or harm. Device has issue
describe
yet to be returned for
the same
evaluation.
event)
Device evaluated by a third
party lab. Complaint
confirmed. Product labeling
states to inspect power cord
for signs of wear or damage.

RESPIRONICS, EVERFLO 0/26/2015 Device had exposed wires to Malfunctio Power

INC the power cord. No reports n cord
of patient harm or injury. issue
Device to be returned for
evaluation.

RESPIRONICS, EVERFLO 12/23/2014 Report that device emitted a Malfunctio Power

INC burning odor and noise. No n cord
report of patient injury or issue
harm. Manufacturer
evaluation found no
evidence of thermal damage
but did observe damage to
the power cord which is
consistent to loose contacts
in an ac outlet.

RESPIRONICS, EVERFLO 10/21/2014 Device plugged into an ac Malfunctio Power

INC outlet. Flames were seen n cord
coming from the outlet. issue
Thermal damage to the plug.
No report of patient injury or
harm.
Third party evaluation found
power cord had evidence of
being chewed. Power cord
replaced.

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Manufacturer Product Event Date Description Event Type Failure

Mode

RESPIRONICS, EVERFLO 8/29/2014 Device plugged into a power Malfunctio Power

INC strip and then plugged into n cord
the wall ac outlet. Flames issue
observed on the power strip.
No report of patient injury or
harm.
Device not returned for
evaluation.

RESPIRONICS, EVERFLO 7/11/2014 Power cord shorted. No Malfunctio Power

INC report of patient injury or n cord
harm. issue

RESPIRONICS, EVERFLO 06/18/2014 Damage to the power cord. Malfunctio Power

INC No report of patient injury or n cord
harm. Device not yet issue
returned to manufacturer.

RESPIRONICS, EVERFLO 10/10/2013 Device had evidence of Malfunctio Power

INC damage to the power cord. n cord
No report of patient injury or issue
harm. Power cord replaced
by third party service center.

RESPIRONICS, EVERFLO 10/03/2013 Device had evidence of Malfunctio Power

INC damage to the power cord. n cord
No report of patient injury or issue
harm. Device not yet
returned for manufacturer
evaluation.

RESPIRONICS, EVERFLO 07/17/2013 Device had evidence of Malfunctio Power

INC damage to the power cord. n cord
No report of patient injury or issue
harm. Device not yet
returned for manufacturer
evaluation.

RESPIRONICS, EVERFLO 08/15/2013 Device had evidence of Malfunctio Power

INC damage to the power cord. n cord
No report of patient injury or issue
harm. Device not yet
returned for manufacturer
evaluation.

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Manufacturer Product Event Date Description Event Type Failure

Mode

RESPIRONICS, EVERFLO 12/16/2013 Flames observed from the Malfunctio Circuit

INC device. No report of patient n Board
injury or harm. Device issue
evaluation revealed thermal
damage caused by the
printed circuit board.

There were 39 reports of injuries for Respironic’s EverFlo device.

The most frequently reported injury involved receiving burns from smoking while using the device
(9). The remaining reported injuries were ‘may have caused or exacerbated a medical condition’ (8),
low blood oxygen resulting from ‘oxygen delivery issues’ (8), smoke inhalation or burns resulting
from ‘fire’ (6), low blood oxygen resulting from ‘solenoid valve issues’ (3). Additional injury reports
were burns from either the nasal cannula (1) or a spark from a nebulizer (1), electrical shock from an
electrical issue (1) and low oxygen from a locked compressor (1). There was one injury whose cause
was not specified.

Product labeling was evaluated for the events that involved smoking while using the device and
found to be sufficient as product labeling does instructs the user not to smoke while using the
device.

No definitive evidence was found linking the device to having caused or exacerbated a medical
condition.

The device was returned for evaluation in 7 of the 8 situations involving low blood oxygen as a result
of oxygen delivery issues. The evaluator (s) found the device was operating to design specifications
in 4 of the events, in 1 event the sieve canister was leaking and the filters were dirty and in 1 event
the microdisk tubing was disconnected causing a no flow event. The evaluation is pending for 1
event and the device was not returned for evaluation in 1 event.

The device was not returned for evaluation in 4 of the 6 reported cases of fire. The device was
found not to have caused or contributed to the fire in the other 2 cases.

A detailed analysis of the reported injuries for the EverFlo device is presented in Table 6.

Table 9 EVERFLO – MAUDE Events – Injuries

Manufacturer Product Event Date Description Event Type Failure Mode

RESPIRONICS, EVERFLO 04/14/2015 Complaint that Injury

Smoking while
INC the nasal using the device
cannula caught

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on fire from a lit

cigarette and
burned the
patient on the
nose. Patient
did not seek
medical
treatment.
Third party
service center
evaluated the
product and
found no
malfunction.
Product labeling
warns against
using near open
flames.
Manufacturer
concluded user
error caused
the event.

RESPIRONICS, EVERFLO 12/07/2014 Report that Injury Smoking while

INC patient using the device
received burns
to the face
while using the
device while
smoking. The
patient was
admitted to the
hospital.

RESPIRONICS, EVERFLO 09/17/2014 Patient lit a Injury Smoking while

INC cigarette while using the device
using the
device. Patient
received burns
and respiratory
complications.
Admitted to the
hospital for
treatment.

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Manufacturer Product Event Date Description Event Type Failure Mode

RESPIRONICS, EVERFLO 04/20/2014 Patient smoking Injury Smoking while

INC while using the using the device
device. House
fire reported.
Patient
hospitalized.
Device not
returned for
evaluation
(destroyed in
fire).

RESPIRONICS, EVERFLO 03/18/2014 Patient smoking Injury Smoking while

INC a cigarette using the device
while using the
device.
Received burns
and was
hospitalized for
treatment.
Device not
returned for
evaluation due
to extensive
damage
received during
the fire.
Product labeling
states do not
smoke when
the
concentrator is
in use.

RESPIRONICS, EVERFLO 12/13/2013 Injury Smoking while

Patient was
INC smoking while using the device
using the
device.
Received burns
and was
admitted to the
hospital for
treatment.
Device
evaluation

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Manufacturer Product Event Date Description Event Type Failure Mode

determined fire
originated
external to the
device. Product
labeling states
do not smoke
when
concentrator is
in use.

RESPIRONICS, EVERFLO 06/17/2013 Patient smoking Injury Smoking while

INC while using using the device
device and
ignited a fire.
Received severe
burns and
admitted to the
hospital for
treatment. The
device was
destroyed in
the fire.

RESPIRONICS, EVERFLO 01/15/2013 Patient burned Injury Smoking while

INC while using the using the device
device and
smoking.
Manufacturer
evaluation
confirmed
thermal
damage
originated
external to the
device. The
device operated
according to
specification.

RESPIRONICS, EVERFLO 05/14/2012 Injury Smoking while

Patient smoking
INC while using the using the device
device and
received burns.
Unknown if
medical
attention was

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Manufacturer Product Event Date Description Event Type Failure Mode

required.
Device not
returned for
evaluation.

RESPIRONICS, EVERFLO 04/28/2015 Complaint that Injury Caused or

INC the device exacerbated a
caused medical
ventricular condition
tachycardia
requiring a visit
to the hospital.
Device
evaluation
pending.

RESPIRONICS, EVERFLO 01/10/2015 Patient claims Injury Caused or

INC odor emitted by exacerbated a
device medical
damaged his condition
lungs. Doctor
visit but no
medical
treatment
required.
Device
evaluation by
the
manufacturer
revealed device
operated to
design
specifications.

RESPIRONICS, EVERFLO 12/11/2014 Report that Injury Caused or

INC device exacerbated a
contributed to a medical
lung infection. condition
No report of
medical
intervention
being required.

RESPIRONICS, EVERFLO 09/03/2014 Injury Caused or

Device may
INC have caused exacerbated a

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Manufacturer Product Event Date Description Event Type Failure Mode

pneumonia. medical
Patient sought condition
medical
treatment.
Manufacturer
investigation
states patient
did not seek
medical
attention.
Device not
returned for
evaluation.

RESPIRONICS, EVERFLO 05/05/2014 Patient has Injury Caused or

INC suffered a exacerbated a
respiratory and medical
sinus infection condition
while using the
device. Patient
admitted to
hospital for
treatment.
Follow Up to
Follow.

RESPIRONICS, EVERFLO 01/09/2014 Patient Caused or

Injury
INC complained of exacerbated a
and odor. medical
Patient condition
contracted a
mold infection
after using the
device.
Physician
prescribed
antibiotics. A
third party
evaluator did
not confirm the
odor. Device to
be returned to
manufacturer
for evaluation.

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RESPIRONICS, EVERFLO 09/26/2013 Device caused Caused or

Injury
INC patient to have exacerbated a
asthma. medical
According to condition
the patient, the
device contains
phthalates
which can cause
asthma. Device
not yet
returned for
manufacturer
evaluation.

RESPIRONICS, EVERFLO 04/30/2013 Device emitted Injury Caused or

INC a white powder exacerbated a
substance medical
which was condition
inhaled by the
patient. The
patient became
congested. She
was prescribed
medications by
her doctor.
Device not yet
returned for
manufacturer
evaluation.

RESPIRONICS, EVERFLO 2/10/2015 Patient claims Injury Oxygen delivery

INC device did not
deliver oxygen
and did not
alarm. Patient
admitted to the
hospital one
week for low
blood oxygen
levels. Device
evaluation by
the
manufacturer
revealed device
operated to

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design
specifications

RESPIRONICS, EVERFLO 1/14/2015 Injury Oxygen delivery

Patient claims
INC concentrator
did not provide
enough oxygen
resulting in low
blood oxygen
levels and a
hospital stay of
10 days.
Device
evaluation by
the
manufacturer
revealed device
operated to
design
specifications
and did not
cause or
contribute to
the injury.

RESPIRONICS, EVERFLO 01/07/2015 Patient’s blood Injury Oxygen delivery

INC oxygen level
was low while
using the
device. Patient
switched to
back up oxygen.
No medical
intervention
required. Third
party service
center
determined
sieve canister
leaking and
filters dirty.

RESPIRONICS, EVERFLO 05/12/2014 Device not Injury Oxygen delivery

INC producing
oxygen.
Patient’s blood

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oxygen
saturation
decreased.
Patient placed
on
supplemental
oxygen. Device
returned for
evaluation.
Follow Up to
follow.

RESPIRONICS, EVERFLO 02/05/2013 Patient’s blood Oxygen delivery

Injury
INC oxygen was low
when using the
device. Patient
admitted to
hospital for
respiratory
distress. Third
party supplier
reported
device was used
with 49 ft
oxygen tubing
and that the
nasal cannula
was not
manufactured
by Respironics.
The device was
tested by the
supplier and
found to
operate
properly.

RESPIRONICS, EVERFLO 11/19/2012 Patient Oxygen delivery

Injury
INC hospitalized for
low blood
oxygen
saturation while
using the
device.
Manufacturer

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evaluation
revealed the
device was
operating to
design
specifications.

RESPIRONICS, EVERFLO 06/29/2012 Device would Injury Oxygen delivery

INC not go above 3L
per min.
Patient did seek
medical
attention.
Device not yet
returned to
manufacturer
for evaluation.

RESPIRONICS, EVERFLO 5/29/2012 Concentrator Oxygen delivery

Injury
INC had no flow
when used with
a ventilator.
Patient’s blood
oxygen level
decreased and
the patient was
hospitalized.
The device was
evaluated by
the
manufacture
and the internal
microdisk
tubing was
disconnected
causing a no
flow event.

RESPIRONICS, EVERFLO 11/25/2013 Device caught Fire

Injury
INC fire while in
use. Patient
taken to the
hospital –
treated and
released for

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smoke
inhalation.
Device not yet
returned for
manufacturer
evaluation.

RESPIRONICS, EVERFLO 11/25/2013 Device caught Injury Fire

INC fire while in
use. Open
flame present.
Patient received
minor burns
and was treated
by a doctor in
her home.
Device not yet
returned for
manufacturer
evaluation.

RESPIRONICS, EVERFLO 09/25/2013 Device involved Fire

Injury
INC in a house fire.
Patient
hospitalized.
Family member
treated for
smoke
inhalation.
Device not
returned for
manufacturer
evaluation. Fire
scene
investigated
and device
located in a
different area
from origin of
fire. Device did
not cause or
contribute to
fire.

RESPIRONICS, EVERFLO 08/20/2015 Device caught Injury Fire

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Manufacturer Product Event Date Description Event Type Failure Mode

INC on fire while in

use. Patient
received burns
and was
hospitalized.
Device not yet
returned for
manufacturer
evaluation.

RESPIRONICS, EVERFLO 05/29/2013 Device caught Fire

Injury
INC on fire. Patient
taken to
hospital and
released.
Manufacturer
evaluation
found thermal
damage
externally
which was
caused by an
external source.

RESPIRONICS, EVERFLO 02/05/2013 Device involved Fire

Injury
INC in a fire. Patient
received burns
and was
hospitalized.
Device is not
being returned
to
manufacturer.

RESPIRONICS, EVERFLO 12/13/2013 Solenoid Valve

Complaint of Injury
INC low oxygen Issue
concentration
causing the
patient’s
disease
(emphysema)
to worsen.
Device
evaluation
revealed faulty
solenoid and

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loose flow
meter screw
and leaking
sieve.

RESPIRONICS, EVERFLO 11/08/2013 Device did not Solenoid Valve

Injury
INC work properly. Issue
Patient
admitted to
hospital.
Patient has
returned to
baseline. Third
party service
center found
solenoid valve
not shifting
properly.

RESPIRONICS, EVERFLO 10/24/2013 Device alarming Solenoid Valve

Injury
INC and not Issue
providing
oxygen. Patient
hospitalized.
Manufacturer
evaluation
revealed
solenoid pilot
valve sticking.

RESPIRONICS, EVERFLO 11/29/2012 Patient received Injury Spark from a

INC burns when a nebulizer
spark from the
nebulizer
(unknown
manufacturer)
ignited the
nasal cannula
connected to
the device.
Patient was
hospitalized.
Manufacturer
evaluation
revealed no

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evidence of
thermal
damage to the
device and that
it was operating
according to
design
specifications.

RESPIRONICS, EVERFLO 10/0/02012 Compressor

Device not Injury
INC producing Locked
oxygen. Patient
admitted for
low blood
oxygen.
Discharged
after one day.
Manufacturer
evaluation
revealed
compressor was
locked and not
producing
oxygen.

RESPIRONICS, EVERFLO 12/12/2013 Shock received Injury Electrical issue

INC while
concentrator
being serviced.
No medical
invention
needed. Device
not yet
returned to
manufacturer
for evaluation.

RESPIRONICS, EVERFLO 10/16/2012 Nasal cannula

Injury Nasal cannula
INC caught on fire
while the
device was in
use. Patient
received burns
and was treated
at the hospital.
Device

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evaluation
revealed no
evidence of
thermal
damage. Nasal
cannula was not
returned.
Failure mode
consistent with
patient
smoking.

RESPIRONICS, EVERFLO 02/03/2014 Device Injury NS

INC malfunctioned
and patient
hospitalized.

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Appendix H: IFU document number or IFU

DeVilbiss 5 Liter Oxygen Concentrator Instruction Guide

SE-252K Rev G

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Model 306DS Instruction Guide

A-306-1 Rev F

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Appendix I: Risk Analysis Report number or Risk Files

Risk Management Report 525 ISO14971
306D Risk Management report per ISO14971-200 Rev 1

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Appendix J: Justification of the choice of the evaluator(s) (ie.

curriculum vitae / biographical sketch of medical writer and
clinical reviewer)
Dr Wilkinson was selected as author of this CER for the following reasons:
• Dr Wilkinson is employed by a leading contract research organisation.
• Dr Wilkinson has extensive experience authoring CERs.
• Dr Wilkinson is an independent unbiased author.

Curriculum vitae

GENERAL INFORMATION
Name and Surname Beata Wilkinson
Surname prior to 2012 Langlands
Place of birth Warsaw, Poland
Nationality British
Mother tongue Language Bilingual – English and Polish
Present Job Position Head of Regulatory Services Unit / Regulatory and Scientific Writing Manager
EDUCATION

Education PhD; Doctoral Thesis in Biomedical Science

Institution – City (Country) The University of Glasgow, UK
Date 1981

Education BSc (Hons) in Molecular Biology

Institution – City (Country) The University of Glasgow, UK

LANGUAGE SKILLS

Language English Level 4

Language Polish Level 4

Language Level

Level 1: Beginner understands read and spoken language, not able to clearly formulate his thoughts in the given language, makes grammar mistakes and
uses very basic vocabulary when speaking or writing.

Level 2: Speaking skills are better but the vocabulary used and sentence structures are still basic; makes pronunciation mistakes, lacks fluency.

Level 3: Comfortable speaker and writer, can build more complex structures and formulate thoughts in a clear manner, makes some grammar mistakes.
Level 4: Experienced and fluent user, pronunciation & accent are correct, speaking rhythm is regular, writing skills are developed, language used is rich.

PROFESSIONAL EXPERIENCE/CAREER HISTORY

Company CROMSOURCE

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Job Position Head of Regulatory Services Unit / Regulatory and Scientific Writing Manager
Date (from-to) 13/Oct/2014 – ongoing
Responsible for the growth objectives, revenue and value added of the Regulatory Services
Unit. My remit is to ensure timely delivery of regulatory services with high quality standards
to CROMSOURCE Clients.
Responsible for delivery of writing services to CROMSOUCE Clients. This includes
Main tasks and preparing and writing CERs and other regulatory and scientifically-sound documents.
Responsibilities:
Wrote two white papers for publication on CROMSOURCE website:
• Clinical Evaluation Reports: Meeting the demands of a more stringent regulatory
environment
• Clinical Data for Medical Device: Preparing for increased requirements in the EU

Company ConvaTec International UK Ltd

Job Position Clinical Evaluation Program Specialist, Clinical & Regulatory Affairs Department
Date (from-to) June 2013 – October 2014
Responsible for the preparation of the company’s Clinical Evaluation Reports (CERs) in
accordance with the Medical Device Directive (MEDDEV 2.7.1) including coordination and
scheduling of resources. Preparation of CERs involved evaluation of preclinical data, risk
assessments, scientific literature, clinical investigations, complaints and other relevant data
sets.
Responsible for preparation of CERs for audits by Notified Bodies.
Responsible for training and supervision of other in-house medical writers and liaison with
Main tasks and external medical writing agencies
Responsibilities, if
relevant for your Participation in cross-functional product development teams
present position:
Achievements:
Raised general awareness of the key role of CERs in the company’s product design
validation process
Developed a new and improved internal Standard Operating Procedure focused on Clinical
Evaluation
Developed a new CER template to reduce the average time of CER preparation

Company Biophoenix Biomedical Consultancy Ltd

Job Position Research Director/Medical Writer

Date (from-to) July 1998 – June 2013

I co-founded Biophoenix Ltd in 1998 with the late Dr Sreten Bogdanovic to provide timely
regulatory, scientific and market information to pharmaceutical and medical device
companies.
Researched and wrote over 50 off-the-shelf biomedical business reports.
Main tasks and
Responsibilities, if Wrote marketing copy and instructed sales teams which resulted in our reports being sold to
relevant for your
present position:
many of the world’s leading organisations, including: pharmaceutical multinationals (for
example Roche, Pfizer, and Novartis); management consulting firms (for example Boston
Consulting Group); and universities (for example John Hopkins School of Medicine).
Liaised closely with major publishing companies and secured significant repeat business.
Established a comprehensive, proprietary database of pharmaceutical companies and their

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products.
Audited biotechnology-based enterprises with regard to the risk of intellectual property
litigation on behalf of Lloyds of London insurers.
During the period December 2010 – June 2013 I worked on commissioned projects for
publishers of healthcare market intelligence reports aimed at customers in the
pharmaceutical and medical device industries.
Generated ideas for new studies and submitted proposals, in addition to accepting work
assignments. My main client was Datamonitor (part of Informa plc).
Duties included: data collection and collation; data processing and analysis; telephone
interviews with healthcare industry executives; preparation of written reports; presentation
of study findings; and production of marketing collateral to support the sales of reports.
A report written by me for Datamonitor (Point-of-Care Testing) was used as a model for
other authors to emulate.

Company Coventry University, UK

Job Position Senior Lecturer in the Department of Biological Sciences
Date (from-to) October 1989 – June 1998
I taught a wide variety of undergraduate courses in biological sciences at degree and
postgraduate level and supervised students carrying out research projects.
Main tasks and Appointed Course Tutor for the European MSc in Biotechnology which enabled me to
Responsibilities, if
relevant for your secure industrial placements for students in prominent healthcare companies.
present position: Developed and taught a final-year undergraduate BSc course module entitled “Biochemical
diagnosis of disease”, which led to the establishment of a new degree in Biomedical
Science.

Company Orbec Ltd

Job Position Project Leader
Date (from-to) 1984-1985

Main tasks and

Responsible for the development of applications for a novel automated microbiological urine
Responsibilities, if screening analyser. The initial work included assessment and development of the unit itself
relevant for your in order to provide reliable and reproducible operation. Further work was concerned with
present position:
carrying out clinical trials.

Company Public Health Laboratory, Coventry and Birmingham Heartlands Hospital, Birmingham
Job Position Hospital Scientist
Date (from-to) 1980-1984
Routine and research work in clinical diagnostic testing and disease surveillance.
Main tasks and
Responsibilities, if Responsibilities included performing specialist assays for the investigation of complement
relevant for your function in disease.
present position:
Duties involved the development of new tests and improvement of existing techniques.

CLINICAL RESEARCH EXPERIENCE

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Countries
Therapeutic area (pathology) Phase Main responsibilities
Managed

 Project management  Document management

 Feasibility  Management of AE/SAE
 All CRA activities  Safety reporting
Wound care EU CE mark
 Clinical Monitoring  Auditing
 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

 Project management  Document management

 Feasibility  Management of AE/SAE
 All CRA activities  Safety reporting
Critical care EU CE mark
 Clinical Monitoring  Auditing
 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

 Project management  Document management

 Feasibility  Management of AE/SAE
 All CRA activities  Safety reporting
Ostomy and continence CE mark
 Clinical Monitoring  Auditing
 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

PUBLICATIONS
Advances in Gene Therapy for Human Diseases (Datamonitor, 2013)
Advances in the Use of Biomarkers in Biochip and Microarray Testing (Business Insights, 2009)
Angiogenesis Modulators: Strategies for Drug Discovery (D&MD, 2005)
Angiogenesis Players (Financial Times Pharmaceuticals, 1999)
Angiogenesis: A Therapeutic and Market Outlook (PJB Publications, 2002)
Antibody-Drug Conjugates in Cancer Therapy (Datamonitor, 2013)
Apoptosis 2009: Opportunities in Cancer and Other Diseases (Biophoenix, 2009)
Biomedical Patents in the Postgenomic Era: Proprietary Drug Targets and Therapies (D&MD, 2005)
Biosimilars and Biobetters: Positioning for a New Market (Biophoenix, 2009)
Biosimilars, Biogenerics, and Follow-On Biologics (Scrip/Informa, 2007)
Cancer Therapeutics (Financial Times Pharmaceuticals, 1998)
Convergence of Biomarkers and Diagnostics (Business Insights, 2008)
Dyslipidemia: Opportunities in Cardiovascular Risk Reduction (Biophoenix, 2008)
nd
Gene Therapy Players, 2 edition (Financial Times Pharmaceuticals, 1999)
Immunodiagnostics and Nucleic Acid Testing Kits for the Veterinary Industry (PJB Publications, 2003)
Immunomodulators (Business Insights, 2007)
Innovations in Bioinformatics (Business Insights, 2008)
Innovations in Molecular Diagnostics for Infectious Diseases (Business Insights, 2011)
Innovations in Protein Kinase Therapies: Company pipelines, therapeutic applications, and market forecasts
(Business Insights, 2009)

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Kinases: Advanced Strategies and Multiple Targets for Drug Discovery (D&MD, 2006)
Lifestyle Drugs: New Opportunities in Obesity (Nicholas Hall & Company, 2001)
Lifestyle Drugs: New Opportunities in Rejuvenation Pharmaceuticals (Nicholas Hall & Company, 2001)
Lifestyle Drugs: New Opportunities in Sexual Dysfunction (Nicholas Hall & Company, 2001)
Livestock Performance Products and Markets (Animal Pharm/Informa, 2007)
Metabolic Syndrome: New Opportunities in Diagnostics and Therapeutics (D&MD, 2004)
Micro and Nano Technologies for Point-of-Care Testing (Datamonitor, 2012)
rd
Molecular Diagnostics: Effective Tools for Disease Management, 3 edition (D&MD, 2006)
nd
Molecular Diagnostics: Transforming the Pharmaceutical Market, 2 edition (D&MD, 2004)
Molecular Diagnostics: Transforming the Pharmaceutical Market (D&MD, 2002)
Next-Generation Protein and Peptide Therapeutics (Business Insights, 2011)
Next Generation Protein Engineering and Drug Design (Business Insights, 2007)
Oligonucleotide Players (Financial Times Pharmaceuticals, 1999)
Pharmacogenomics Players (Financial Times Pharmaceuticals, 1999)
Point-of-Care Testing (Business Insights, 2010)
Proteases as Drug Targets: Technologies and Opportunities for Drug Discovery (D&MD, 2004)
Protein Kinases: Technologies and Opportunities for Drug Discovery (D&MD, 2003)
Smarter Ways to Diagnose Cardiovascular and Heart Disease (PJB Publications, 2003)
Stem Cells: Identifying Commercial Opportunities (Reuters, 2006)
Systems Biology: The future of integrated drug discovery (PJB Publications, 2004)
The Emerging Drug Targets Outlook: An Analysis of Novel Molecular Targets (Reuters, 2005)
The Future of In Vitro and In Vivo Diagnostic Integration (Business Insights, 2011)
The Future of RNAi Therapeutics: Drug Pipelines and Prospects (Business Insights, 2008)
The Outlook for the Biotech Sector in the Post-Genomic Era (Reuters, 2002)
Theranostics: Commercial Opportunities for Diagnostic and Pharmaceutical Companies (D&MD, 2001)
Transmembrane Transporters: High Sales, High Potential (D&MD, 2006)
Veterinary Immunodiagnostics - A Global Survey (PJB Publications, 2000)

OTHER CERTIFICATIONS RELEVANT FOR YOUR POSITION/ ORGANIZATIONS MEMBERSHIP

In October 2013 I completed a Clinical Evaluation for Medical Devices Training Course delivered by BSI
(British Standards Institution). As a Notified Body under the Medical Devices Directives, BSI has one of the
broadest scopes of any Notified Body.

TRAININGS AND COURSES: Professional Development Log – available on request as attachment to this CV

COMPUTER/TECHNICAL SPECIFIC COMPETENCES

Systems: N/A
Program Languages: N/A
Software:
N/A
(in addition to Microsoft Package)

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I, the undersigned, in relation to all the projects and activities conducted within CROMSOURCE, to all
the information and connected material and, furthermore, to the intellectual property rights,

Declare:

- to keep strictly confidential all information, data and strategies which will be
communicated by CROMSOURCE;

- to maintain all the documentation and the materials strictly confidential and not to
disclose their content, wholly or in part, to any third party;

- to strictly limit this documentation only to those collaborators who necessarily

require access to it for the purpose of their job, who have been informed of its
confidential nature and who are obliged to keep the secret;

- not to use this documentation in any way, except for the purpose agreed upon with
CROMSOURCE;

- to be aware, and to authorize accordingly since now, that the present Curriculum
Vitae, with all the information contained, can be made available within the Company
and to Competent Authorities, concerned Clients and Auditors in general.

I authorize the treatment of my data according to the applicable local regulation about data protection
and any further amendments (Data Protection Act)

Signature: _______________ Date: 6 April 2014

_____________

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Dr. Malgorzata Kaczorowska was selected as the Expert Reviewer for this CER for the following
reasons:
• Dr. Kaczorowska is an ENT Specialist who has almost 20 years of experience in the medical
profession.
• Dr. Kaczorowska has extensive experience with and knowledge of medical devices used for
the treatment of respiratory disease
• Dr. Kaczorowska was trained on the CROMSOURCE CER SOP on August 1, 2015

GENERAL INFORMATION
Name and Surname Malgorzata Kaczorowska
Date of birth 16/Oct/1970
Place of birth Warsaw
Nationality Polish
Mother tongue Language Polish
Present Job Position Medical Monitor

EDUCATION

Specialist in Audiology and Phoniatry;

Education
Board Certification in Audiology and Phoniatry Certificate No. 0733/2013.1/3
Institution – City (Country) Ministry of Health, Poland
Date 2013

ENT Specialist;
Education
Board Certification in Otorhinolaryngology Certificate No. 0721/2005.2/16
Institution – City (Country) Ministry of Health, Poland
Date 2005

Education PhD; Doctoral Thesis in Medicine, Clinical Immunology

Institution – City (Country) Medical University of Warsaw, Poland
Date 2004

Education MD; Faculty of Medicine Certificate No. L15800/28688/96

Institution – City (Country) Medical University of Warsaw, Poland
Date 1996

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LANGUAGE SKILLS

Language English Level 4

Language Spanish Level 1

Language Russian Level 1

Level 1: Beginner understands read and spoken language, not able to clearly formulate his thoughts in the given language, makes grammar mistakes and
uses very basic vocabulary when speaking or writing.

Level 2: Speaking skills are better but the vocabulary used and sentence structures are still basic; makes pronunciation mistakes, lacks fluency.

Level 3: Comfortable speaker and writer, can build more complex structures and formulate thoughts in a clear manner, makes some grammar mistakes.
Level 4: Experienced and fluent user, pronunciation & accent are correct, speaking rhythm is regular, writing skills are developed, language used is rich.

PROFESSIONAL EXPERIENCE/CAREER HISTORY

Company CROMSOURCE
Job Position Medical Monitor
Date (from-to) Sep/2014 - ongoing
Is clinical advisor for the entire lifecycle of the clinical trial by answering to medical
questions
Participates actively in the project meetings by giving his/her medical advice
Main tasks and
Responsibilities:
Reviews study data listing from a medical point of view
Analyses and makes an independent interpretation of study data/results
Writes and/or reviews protocol, Care Report Form (CRF) and Clinical Study Reports (CSR)
Provides training in specific disease/therapeutic area

Company COVANCE
Job Position Clinical Research Associate
Date (from-to) Nov/2013 – Aug/2014
Main tasks and Responsible for all aspects of study site monitoring and management, CRF review, query
Responsibilities, if
relevant for your generation and resolution, tracking and following-up on serious adverse events. Involved in
present position: the administration of clinical research project and managing investigator site budgets.

Company ENT Department of The Children's Memorial Health Institute, Warsaw, Poland
Job Position Physician

Date (from-to) Feb/2012 – Nov/2013

Main tasks and ENT/audiology consultant for patients of The Children's Memorial Health Institute, Warsaw,
Responsibilities, if
relevant for your Poland. Providing evaluation and treatment of a board range of inborn and acquired ear,
present position: nose and throat disorders.

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Company 8.1.1 Institute of Hearing Physiology and Pathology, Warsaw, Poland

Job Position Physician
Date (from-to) Feb/2009 – Feb/2012
Main tasks and
Responsibilities, if Providing care for patients with problems related to hearing loss, tinnitus and hyperacusis,
relevant for your vertigo and balance disorders, speech and voice disorders.
present position:

Company Medical Network CRO, Warsaw, Poland

Job Position Medical Monitor

Date (from-to) Dec/2009 – Nov/2010

Main tasks and As medical monitor responsible for providing supervision and coordination of medical issues
Responsibilities, if
relevant for your related to clinical research including: protocol clarifications, inclusion/exclusion
present position: determinations, issues of patient safety.

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PROFESSIONAL EXPERIENCE/CAREER HISTORY

Company Medical Network CRO, Warsaw, Poland
Job Position Clinical Research Associate
Date (from-to) Mar/2007 – Jan/2009

Main tasks and As CRA responsible for feasibilities, site selection, all aspects of study site monitoring and
Responsibilities, if
relevant for your management, CRF review, query generation and resolution, track and follow-up on serious
present position: adverse events.

Company Department of ENT, Medical University of Warsaw, Poland

Job Position Physician
Date (from-to) 2000 – Mar/2007

Providing evaluation and treatment for patients with ear, nose and throat disorders.
Area of special interest
Main tasks and Otology and neurootology. As a member of Cochlear Implant Program team involved in
Responsibilities, if assessment of candidacy requirements, surgery, postoperative care, speech processor
relevant for your
present position: fitting and hearing rehabilitation in deaf patients.
Rhinology- providing medical and surgical treatment of patients with diseases of the nose
and sinuses including chronic rhino-sinusitis and Aspirin-exacerbated respiratory disease
(AERD).

Company Department of Pediatric ENT, Medical University of Warsaw, Poland

Job Position Physician
Date (from-to) 1997-1999
Main tasks and
Responsibilities, if
relevant for your Providing care for pediatric patients with a board range of ear, nose and throat disorders.
present position:

Company
Department of Laboratory Diagnostics and Clinical Immunology, Medical University of
Warsaw, Poland
Job Position Researcher; Postgraduate Research Study
Date (from-to) 1997 – 2003

Main tasks and Performing laboratory assays in haematology, chemistry and immunology. Area of special
Responsibilities, if
relevant for your interest - diagnosis of immunodeficiency, diagnosis and monitoring of leukaemia and
present position: lymphoma by flow cytometry. Involved in research studies on primary immunodeficiency.

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CLINICAL RESEARCH EXPERIENCE

Therapeutic area (pathology) Countries Managed Phase Main responsibilities

Europe  Project management  Document management

 Feasibility  Management of AE/SAE

Asthma - long acting inhaled  All CRA activities  Safety reporting

IIb
muscarinic antagonist  Clinical Monitoring  Auditing
 Regulatory submissions  Data Management
Medical Monitoring  Statistics

Europe  Project management  Document management

 Feasibility  Management of AE/SAE

COPD –long acting inhaled  All CRA activities  Safety reporting

II
muscarinic antagonist  Clinical Monitoring  Auditing
 Regulatory submissions  Data Management

Medical Monitoring  Statistics

Central Europe  Project management  Document management

 Feasibility  Management of AE/SAE
Preeclampsia - apheresis  All CRA activities  Safety reporting
treatment with high affinity I/II
antibody adsorption column  Clinical Monitoring  Auditing
 Regulatory submissions  Data Management

Medical Monitoring  Statistics

 Project management  Document management

 Feasibility  Management of AE/SAE
Cirrhosis with refractory and  All CRA activities  Safety reporting
recurrent ascites – USA, Canada IV
implantable alfa-pump system  Clinical Monitoring  Auditing
 Regulatory submissions  Data Management

Medical Monitoring  Statistics

 Project management  Document management

 Feasibility  Management of AE/SAE
 All CRA activities  Safety reporting
Alzheimer’s Disease - Tau Americas, Europe,
III
Aggregation Inhibitor (TAI) Asia, Australia  Clinical Monitoring  Auditing
 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

 Project management  Document management

 Feasibility  Management of AE/SAE
Behavioral Variant
 All CRA activities  Safety reporting
Frontotemporal Dementia Americas, Europe,
III
(bvFTD) - Tau Aggregation Asia, Australia  Clinical Monitoring  Auditing
Inhibitor (TAI)
 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

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 Project management  Document management

 Feasibility  Management of AE/SAE
Breast cancer  All CRA activities  Safety reporting
Central Eastern
III
- antineoplastic monoclonal Europe  Clinical Monitoring  Auditing
antibodies
Regulatory submissions  Data Management

 Medical Monitoring  Statistics

Breast cancer  Project management  Document management

- antineoplastic monoclonal  Feasibility  Management of AE/SAE

antibodies  All CRA activities  Safety reporting
Central Eastern
II
Europe  Clinical Monitoring  Auditing

Regulatory submissions  Data Management

 Medical Monitoring  Statistics

Central Eastern  Project management  Document management

Europe
 Feasibility  Management of AE/SAE
Renal transplantation:  All CRA activities  Safety reporting
immunosuppressive III
 Clinical Monitoring  Auditing
- calcineurin inhibitor
Regulatory submissions  Data Management

 Medical Monitoring  Statistics

Central Eastern  Project management  Document management

Europe
 Feasibility  Management of AE/SAE
Pediatric renal transplantation:  All CRA activities  Safety reporting
immunosuppressive II
 Clinical Monitoring  Auditing
- calcineurin inhibitor
Regulatory submissions  Data Management

 Medical Monitoring  Statistics

Central Eastern  Project management  Document management

Europe
 Feasibility  Management of AE/SAE
Prostate cancer  All CRA activities  Safety reporting
II
- alpha particle emitting  Clinical Monitoring  Auditing
radiopharmaceutical
 Regulatory submissions  Data Management

 Medical Monitoring  Statistics

Central Eastern  Project management  Document management

Europe
 Feasibility  Management of AE/SAE
Hypercholesterolemia  All CRA activities  Safety reporting
III
- CETP inhibitor  Clinical Monitoring  Auditing
 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

Central Eastern  Project management  Document management

Schizophrenia in adults Europe
III  Feasibility  Management of AE/SAE
- dopamine/serotonin
stabilizer IM depot  All CRA activities  Safety reporting

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 Clinical Monitoring  Auditing

 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

Central Eastern  Project management  Document management

Europe
 Feasibility Management of AE/SAE
Bipolar 1 Disorder  All CRA activities  Safety reporting
III
- MT1/MT2 agonist  Clinical Monitoring  Auditing
 Regulatory submissions  Data Management
 Medical Monitoring  Statistics

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PUBLICATIONS

Papers published under the name M.Kowalska till 2005 year

M.Kaczorowska MIFurmanek PKlimek HSkarżyński Iatrogenic internal carotid artery pseudoaneurysm as a complication
of myryngotomy in 6-years-old boy Otolar. Pol. 2012; Vol.66; p368-372;
Kazimierz Niemczyk, Agnieszka Olejniczak, Malgorzata Kaczorowska, Lidia Mikolajewska, Katarzyna Pierchala,
Krzysztof Morawski, Arkadiusz Paprocki Vestibular function in cochlear implant candidates Otolar. Pol. 2009; Vol.63;
p168-170.
Kazimierz Niemczyk, Antoni Bruzgielewicz, Krzysztof F. Morawski, Malgorzata Kaczorowska, Lidia Mikolajewska, Olimpia
Stanislawska-Sut Residual Hearing Status after Implantation of Various Types of Cochlear Implant Electrodes.
Otolaryngology - Head and Neck Surgery 2005, Vol.133, Iss.2, Supplement, p P135
Maria Wąsik, M. Kaczorowska, U. Demkow. Altered expression of immune surface markers in children with recurrent
infections of respiratory tract. J. Physiol. Pharmacol.2005; Vol.56; Supl.4; p.237-243;
R. Bartoszewicz, K Niemczyk, Andrzej Marchel, M. Kowalska Sudden deafness as a presentation of acoustic neuroma.
Pol. Merk. Lek. 2005; Vol.19; nr 111; p.307-308;

K Pierchała, I Krzeska-Malinowska, M. Kowalska, R. Bartoszewicz, K Niemczyk. Long-term results of the transtympanic

gentamicin treatment in Meniere's disease. Otolar. Pol. 2005; Vol.59; nr 3; p.409-413;

L. Mikołajewska, K Pierchała, M. Kowalska, K. Kochanek, K Niemczyk. Auditory neuropathy – diagnostics and therapy
Otolaryngology – clinical review, 2004,Vol.3, nr 4; p.146-148
M. Kaczorowska, L. Mikołajewska, A Woźniak, J. Piotrowski, Z. Łukaszewicz-Moszyńska, K.Niemczyk Cochlear implants:
qualification procedure in the pediatric population. New Medicine 2004, Vol.4; p.105-108
M Wąsik, B Jakubczak, M Kowalska Phenotypic and functional characteristic of peripheral blood neutrophiles. Laboratory
2004 Vol.7; p.23-27
K Niemczyk, M. Kowalska. Tumors of the ear and temporal bone. Therapy 2003 Vol.. 11 nr 6/1;p. 34-38

I Krzeska-Malinowska, P Podogrodzki, M. Kowalska, K Niemczyk.Transtympanic steroides application in sudden

deafness. Otolar. Pol. 2003 Vol. 57 nr 4; p. 549-553
T. Kucharski, K Niemczyk, M. Kowalska, A Bruzgielewicz, R. Bartoszewicz. Overview of new methods of visualization in
operating field in aspect of inner ear surgery.Otolar. Pol. 2003; Vo.l 57; nr 6; p. 881-887;
K Kądziela, H. Kowalska, B Rymkiewicz-Kluczyńska, M. Kowalska, G Miszkurka, J. Rybczyńska, M Wąsik, E Pańkowska.
Changes in lymphocyte subsets in children with newly diagnosed type 1 diabetes mellitus. J. Pediatr. Endocrinol. Metab.
2003; Vol.16; nr 2; p.185-191

M. Kowalska, H. Kowalska, L Zawadzka-Głos, M Dębska, E. Szerszeń, M Chmielik, M Wąsik. Dysfunction of peripheral

blood granulocyte oxidative metabolism in children with recurrent upper respiratory tract infections. Int. J. Pediatr.
Otorhinolaryngol 2003; Vol. 67; nr 4; p. 365-371

PUBLICATIONS

I Krzeska-Malinowska, M Held-Ziółkowska, M. Kowalska, K Niemczyk The role of immunological factors in Meniere`s

disease. Otolar. Pol.2002 Vol. 56 nr 5; p. 583-587
I Krzeska-Malinowska, K Pierchała, M Held-Ziółkowska, K Niemczyk, M. Kowalska Intratympanic gentamycin application
for the treatment of Meniere`s disease. Otolar. Pol. 2001 Vol. 55 nr 6; p. 623-626
M Wąsik, H Kowalska, B. Gałązka, J Rybczyńska, M. Kowalska, E Wagiel. Flow cytometric detection of leukemia and
lymphoma in the cerebrospinal fluid. Cent. Eur. J. Immunol. 1999 Vol.24 nr 3;p.191-195

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M. Wąsik, M. Chmielik, M. Kowalska, L Zawadzka-Głos, J Rybczyńska, E Górska. Lymphocytes subpopulations

disturbances in children with tonsillar hypertrophy. New Medicine 1999 Vol.3/17; p.246-249

OTHER CERTIFICATIONS RELEVANT FOR YOUR POSITION/ ORGANIZATIONS MEMBERSHIP

8.1.2 Member of Polish Association of Otolaryngologists/Head & Neck Surgeons
Member of Polish Association of Audiologists

TRAININGS AND COURSES: Professional Development Log – available on request as attachment to this CV

COMPUTER/TECHNICAL SPECIFIC COMPETENCES

Systems: Windows 7, Vista, XP

Program Languages: n/a
Software:
Statistica
(in addition to Microsoft Package)

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Appendix K: Clinical Investigation Documents

There are no relevant clinical investigation documents.

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Appendix L: Regulatory References

Active Implantable Medical Device Directive (AIMDD) 90/385/EEC
Global Harmonisation Task Force GHTF/SG5/N4: 2010 Post Market Clinical Follow-up studies
Global Harmonisation Task Force SG5-N2R8: 2007 Clinical evaluation
MEDDEV 2.12.2 rev 2 (Jan 2012) Post Market Clinical Follow-up studies
MEDDEV 2.7.1 rev 3 (Dec 2009) Clinical evaluation: a guide for manufacturers and notified bodies
Medical Device Directive (MDD) 93/42/EEC (consolidated by the 2007/47/CE)
Others (eg. National regulations)
Procedures
Proposal for a Regulation of the European Parliament and of the Council on Medical Devices, and
Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009;
issued 26 Sep 2012

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Appendix M: References
BALFOUR-LYNN, I. M., FIELD, D. J., GRINGRAS, P., HICKS, B., JARDINE, E., JONES, R. C.,
MAGEE, A. G., PRIMHAK, R. A., SAMUELS, M. P., SHAW, N. J., STEVENS, S., SULLIVAN,
C., TAYLOR, J. A., WALLIS, C. & PAEDIATRIC SECTION OF THE HOME OXYGEN
GUIDELINE DEVELOPMENT GROUP OF THE, B. T. S. S. O. C. C. 2009. BTS guidelines for
home oxygen in children. Thorax, 64 Suppl 2, ii1-26.
BOLTON, C. E., ANNANDALE, J. A. & EBDEN, P. 2006. Comparison of an oxygen concentrator and
wall oxygen in the assessment of patients undergoing long term oxygen therapy assessment.
Chron Respir Dis, 3, 49-51.
CHATBURN, R. L., LEWARSKI, J. S. & MCCOY, R. W. 2006. Nocturnal oxygenation using a pulsed-
dose oxygen-conserving device compared to continuous flow. Respir Care, 51, 252-6.
EATON, T. E., GREY, C. & GARRETT, J. E. 2001. An evaluation of short-term oxygen therapy: the
prescription of oxygen to patients with chronic lung disease hypoxic at discharge from
hospital. Respir Med, 95, 582-7.
HARDINGE, M., SUNTHARALINGAM, J. & WILKINSON, T. 2015. Guideline update: The British
Thoracic Society Guidelines on home oxygen use in adults. Thorax, 70, 589-91.
JOHNS, D.P., ROCHFORD, P.D., STREETON, J.A. 1985. Evaluation of six oxygen concentrators.
Thorax. 40:806-10.
LEBLANC, C. J., LAVALLEE, L. G., KING, J. A., TAYLOR-SUSSEX, R. E., WOOLNOUGH, A. &
MCKIM, D. A. 2013. A comparative study of 3 portable oxygen concentrators during a 6-
minute walk test in patients with chronic lung disease. Respir Care, 58, 1598-605.
LOBATO, S. D., RODRIGUEZ, E. P. & ALISES, S. M. 2011. Portable pulse-dose oxygen
concentrators should not be used with noninvasive ventilation. Respir Care, 56, 1950-2.
NASILOWSKI, J., PRZYBYLOWSKI, T., ZIELINSKI, J. & CHAZAN, R. 2008. Comparing
supplementary oxygen benefits from a portable oxygen concentrator and a liquid oxygen
portable device during a walk test in COPD patients on long-term oxygen therapy. Respir
Med, 102, 1021-5.

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