Gaenor Moore

Dolby Viviso

Home Respirat

Martin Fleming, HM Assistant Coroner for Surrey
Woking Coroner’s Court

Station Approach

Woking

Surrey

GU22 7AP

15" January, 2015.
Dear Sir,

The Inquest touching the death of Gaenor Moore (“the Deceased”)
Regulation 28 Report- Action to Prevent Future Deaths dated 24.11.2014 (“the
Report”)

I refer to the above.

The Report instructed Dolby Vivisol (“the Company”) to issue a response to the concerns
raised in the Report and I confirm that I am authorised to respond on the Company’s
behalf in my capacity as Managing Director.

I will first provide a brief background about the Company and then address the concerns
as far as they are applicable to the Company.

The Company

The Company is involved in the supply of specialist respiratory medical equipment to both
NHS and private care homes and other private customers, including the oxygen
concentrator and humidifier (“the Equipment”) being used by the Deceased at the time of
her death. We are mainly concerned with the procurement, installation and delivery of
such equipment, and therefore cannot comment on concerns relating to the manufacture
or design of the Equipment.

When the Company receives an order from a physician to install home oxygen with a
patient we visit the patient’s location, usually their own home or a care home, and
conduct an installation. The installation process is comprised of conducting a risk
assessment to ensure that it is safe to install the Equipment and then we put the
equipment in place, test the equipment to ensure that it is working correctly and train the
patient or their carer how to properly use and maintain the equipment. As reinforcement
to the on-site training we also provide a range of instruction material explaining how to
correctly use individual pieces of equipment as well as more general educational pieces of
information explaining how the patient can stay safe whilst using oxygen therapy and
how the patient can contact the Company via our 24/7 contact centre if they have any
questions or concerns.

The Coroner’s concerns

The Report cited the following three concerns that have arisen following the death of the
Deceased:

Southpoint, Old Brighton Road, Lowfield Heath, Gatwick, West Sussex RH11 OPR
T 01293 575910 F 01293 575911 E info@dolbyvivisol.com W www.dolbyvivisol.com

Dolby Medical Home Respiratory Care Ltd. Registered in Scotland No. 63902. Registered Office: Monitor House, Kerse Road, Stirling FK7 7RZ

Dolbyviviso:

1. “The lack of oxygen flow to the nasal cannula as a result of the screw cap
humidifier not being properly engaged”;

2. “Absence of a visual or audible alarm on concentrator machine (product number
INV-IRC5PO2AWN) to indicate the loss of oxygen flow to the nasal cannula when
the screw cap to the humidifier (manufactured by Salter Labs) was tightened and
cross threaded”;

3. “Accompanying training and literature did not reference the implications to
oxygen flow in the event of failing to properly engage the screw cap to the
humidifier”

I will outline the Company’s response to each of these concerns in turn, and in particular
I will give details of any action which has been taken or planned (as well as a timetable
for such action), or alternatively explain why responsive action is not proposed by the
Company.

1. The lack of oxygen flow to the nasal cannula as a result of the screw cap
humidifier not being properly engaged

As stated above, the Company cannot respond on points relating to the manufacture
or design of the Equipment. Concerns about these issues should properly be
addressed by the manufacturer of the oxygen concentrator and/or humidifier
(Invacare (UK) Limited and Salter Labs respectively).

We do however note your finding that it is more likely than not that “the lack of
oxygen made less than a minimal contribution to [the Deceased’s] death and that she
died from natural causes” (paragraph 3, Investigation and Inquest).

As far as this concern may relate to the installation of such equipment by Company
staff, and/or training of the patient or nursing staff operating the equipment, please
see our response to concern number 3 (below).

2. Absence of a visual or audible alarm on concentrator machine (product
number INV-IRC5PO2AWN) to indicate the loss of oxygen flow to the nasal
cannula when the screw cap to the humidifier (manufactured by Salter Labs)
was tightened and cross threaded

As stated above, the Company cannot respond on points relating to the manufacture
or design of the Equipment. Concerns about the design of the concentrator machine
should properly be addressed by Invacare (UK) Limited.

3. Accompanying training and literature did not reference the implications to
oxygen flow in the event of failing to properly engage the screw cap to the
humidifier

The Company is committed to ensuring the highest levels of patient safety. As such,
we continually review our training procedures and equipment literature to ensure that
it is as comprehensive and up-to-date as possible. As you are aware, full oral
evidence was provided by the Company about this at the Inquest by
Field Services Manager.

Southpoint, Old Brighton Road, Lowfield Heath, Gatwick, West Sussex RH11 OPR
T 01293 575910 F 01293 575911 E info@dolbyvivisol.com W www.dolbyvivisol.com

Dolby Medical Home Respiratory Care Ltd. Registered in Scotland No. 63902. Registered Office: Monitor House, Kerse Road. Stirling FK7 7RZ

The Company currently supplies the patient with a leaflet called “Your Oxygen
Concentrator” which provides details of how the concentrator works, how it is set up,
the care of the concentrator and how to troubleshoot any problems. The leaflet
instructs the patient on how to check the flow, there is also a list of Do’s and Don'ts to
assist the patient with day to day usage. In the event that a patient requires a
humidifier there is a separate leaflet provided at installation. The leaflet provides
details of how to clean, refill and fit the humidifier bottle, it states “take care that you
do not overtighten or cross the screw thread”.

It is proposed that the humidifier leaflet will be modified to provide increased
awareness of the impact caused by failure to connect the humidifier bottle correctly.
Also there will be greater emphasis on the need to confirm the flow of oxygen from
the nasal cannula. These enhancements will be reinforced during the patient/carer
training provided by the Dolby Vivisol technicians.

In light of the concern raised in the Report, I can confirm that the Company is taking
the following action:

3.1 The Company is actively liaising with Salter Labs which manufactures the
humidifier. Salter Labs has proposed additional wording on the product
instructions in order to avoid leaks, and warn about the potential effect of a leak
on the oxygen supply. The Company’s correspondence with Salter Labs is
currently on-going, although I am informed by Salter Labs that updated labels will
be attached to relevant products manufactured after 15 February 2015. Upon
receiving the update from Salter Labs we will correspondingly review and/or
update our instructions and training material.

BZ The Company is actively liaising with Invacare (UK) Limited in relation to
amendments proposed to their current instructions, which will warn about the
potential effect of a failure to properly fasten a humidifier cap to its oxygen
concentrator. The correspondence with Invacare is currently on-going, although I
am told that Invacare proposes to update its instructions within the coming
months. Upon receiving the final update from Invacare we will correspondingly
review and/or update our instructions and training material.

3.8 Once all draft amendments to current literature have been finalised, the proposed
amendments will be sent as soon as possible to NHS contract managers for
approval

3.4 When approval is obtained from the NHS contract managers, the updated
literature will be sent to all current and future Equipment users. The amendments
will be specifically highlighted to current humidifier patients.

3.5 Any amendments will be immediately communicated to the relevant Company
staff, and the nature and effect of the amendments will be specifically reinforced
during the patient/carer training provided by Company technicians when
Equipment is installed in the future.

Southpoint, Old Brighton Road, Lowfield Heath, Gatwick, West Sussex RH11 OPR
T 01293 575910 F 01293 575911 E info@dolbyvivisol.com W www.dolbyvivisol.com

Dolby Medical Home Respiratory Care Ltd. Registered in Scotland No. 63902. Registered Office: Monitor House, Kerse Road. Stirling FK7 7RZ

Yes, you can.

HM Assistant Coroner for Surrey
Martin Fleming

Woking Coroner’s Court

Station Approach

Woking

Surrey

GU22 7AP

15 January 2015

Dear Sir

Inquest touching the death of Gaenor Moore
Regulation 28 Report — Action to Prevent Future Deaths

| write in response to the Regulation 28 report issued on 24'* November 2014 following the
inquest into the death of Gaenor Moore. | am writing in my capacity as Managing Director
on behalf of Invacare (UK) Limited (“Invacare”).

In your report you have highligted a number of concerns and asked that further
consideration is given to equipment and accompanying information to prevent a recurrence
of the death. | will deal with these points further below, in the order they are raised, after
providing background information that Invacare believes is relevant in the circumstances.

Equipment background

Invacare manufacturers concentrator units which are prescribed for supplementary oxygen
for home use. The units are supplied to various customers throughout the United Kingdom,
one of which is Dolby Vivisol. These customers are then responsible for the onward supply
of our units, together with provision of training and literature, to the end user. Invacare
itself has no direct involvement with the end user.

Invacare is aware that a small percentage of oxygen concentrator units are supplied in the
United Kingdom with a humidifer. | can confirm that the company has no involvement with
the provision of this accessory. | provide further detail on this under the heading “Concern 1
- Humidifier”.

INVACARE LIMITED
Pencoed Technology Park Pencoed Bridgend CF35 5AQ UK
Tel: +44 (0)1656 776200 Fax: +44 (0)1656 776201
www.invacare.co.uk
Registered in Cardiff No. 5178693

—~_
Equipment use Yes, you can:

Invacare’s concentrator unit is not intended as life sustaining equipment; as accepted in the
evidence of EE anc EMMY at the inquest. In addition, this fact is expressly
provided for in the international standard that outlines the safety requirements for oxygen
concentrators; ISO 8359.

The purpose of the concentrator unit is explicitly set out in our manuals with this relevant
wording being inserted since December 1999. Each concentrator is packed and delivered
containing a manual and so they are provided as a matter of course to each of our
customers. They in turn extract and provide relevant information from them to caregivers
and patients who use the product. The most up to date version of the manuals are available
on our website and customers are informed that they can access them.

The therapeutic, as opposed to life sustaining, use of the concentrator is widely known
throughout the industry and by relevant parties, from the prescribing physician right
through to the end user. It is common, and should be of no medical concern, for a patient
prescribed a home oxygen unit to have spells off oxygen; also accepted in the evidence of
| od the inquest. It follows therefore, that it is not appropriate for the Invacare unit to be
used for acutely ill patients who require oxygen for life sustaining purposes.

As a result, Invacare respectfully submits that, taking into account the facts and
circumstances relevant to the inquest, and the matters that are the subject of the
Regulation 28 report, appropriate actions have been taken to reduce or eliminate risk as far
as possible to prevent injury or death related to intended use of its equipment.

However, as a responsible organisation committed to continuous improvement, Invacare
has reviewed your report and is responding to each of your concerns as relevant to our
position.

Concern 1 - Humidifer

“The lack of oxygen flow to the nasal cannula as a result of the screw cap to the humidifer
not being properly engaged.”

At the inquest, expert enginec in referred in evidence to an Invacare manual.
This manual referred to our concentrator units being supplied with humidifer bottles. | am
not aware of which version of the manual was relied upon in evidence however | can report
that enquiries were made following the inquest and | confirm that our manuals have not
referred to humdifier bottles supplied with concentrator units for many years. The manual
referred to in evidence is therefore not representative of current or recent past editions of
the concentrator unit manual.

ARES
\ INVACARE
sie)
Yes, you can.
Further, | can confirm that we do not produce or provide humidifer bottles in the United
Kingdom. As such, it is appropriate for Salter Labs, as a manufacturer of humidifier bottles,
to directly address this point in their response.

Concern 2 - Alarm

“ Absence of a visual or audible alarm on concentrator machine (product number INV — IRC
5PO2AWN) to indicate the loss of oxygen flow to the nasal cannula when the screw cap to
the humidifer (manufactured by Salter Labs) was tightened and cross threaded.”

The alarms presently on Invacare’s concentrator unit are in place to properly detect the
output of oxygen from the unit itself and issues such as power failures, degradation of
oxygen quality, blockages in the tubes and overheating of the appliance.

The unit and the alarms present on it are fully compliant with the applicable Oxygen
Concentrator Standards; IEC60601-1 and 1SO8359, as required by the European Medical
Devices Directives. Oxygen concentrators that comply with these standards are recognised
as safe to operate.

1SO8359 set out requirements for manuals in respect of containing appropriate technical
descriptions together with a comprehensive list of warnings to be provided. The required
warnings/alarms are featured on the Invacare concentrator units. The standards do not
require any additional alarms.

Invacare has however still given consideration to whether it is possible to have either a
visual or audible alarm on the concentrator machine that detects the loss of oxygen flow
when the humidifier cap is not properly engaged. The company has concluded that as a
responsible organisation it has properly assessed the risks to the intended user and has
appropriate alarms in place to counter these. Further, it has concluded that an alarm to
indicate loss at the humidifier point would be technically complex such that it would
introduce unacceptable risks and inconvenience to the end user without any benefits to
counter or justify them. Examples of these are:

e The alarm suggested is still no guarantee that the end user is receiving oxygen as
there are the possibility of leaks in the tubing after tne humidifer (which can be up to
40 or 50 feet/10 to 18 meters long for user convenience) or the “fire safe” device
that sits at the patient end of the oxygen line. The only guarantee of oxygen flow
from the humidifer onwards is by monitoring or testing the flow at the cannula end;

e The proposed alarm would require additional lengthy wiring and connection points
which may increase the potential for leaks and as a result, erroneous alarms, or the
potential for wiring problems. There is then a greater risk of the user ignoring all/any
alarm;

Yes, you can.

e There can be potential confusion in patients on flow rates prescribed and that which
is detected by an alarm (as there can be a loss of up to 0.5 litres of flow after the
oxygen goes through the humidifier);

e The proposed alarm would have to be put as close as possible to the user which
would as a result tether a much shorter area of use therefore preventing the user
walking freely around their house as would be expected, add risk from additonal
weight and potentially excessive wiring, potentially cause a trip hazard and possibly
promote non-compliance due to the encombering nature of the device.

Invacare’s position is supported by the evidence given at the inquest by expert engineer;
«| vote that the initial view expressed by [J was that
consideration should be given to such an alarm however he qualified this by stating it would
be difficult to do so. | understand that subsequently in his evidence EEN accepted
that there were sensible alarms on Invacare’s unit and that there was no need for any
additional alarms.

Concern 3 — Training & Literature

“ Accompanying training and literature did not reference the implications to oxygen flow in
the event of failing to properly engage the screw cap to the humidifer”

As stated earlier, Invacare does not have any direct involvement with any training or
literature provided to the end user. Specifically, we have no involvement at all with any
humidifer bottles that may be added on as an accessory to our concentrator units. Suppliers
such as Dolby Vivisol are directly responsible for providing the training and literature
provided to the end user. Invacare therefore consider, save for a few points as noted below,
that it is appropriate for Dolby Vivisol to take the lead in respect of this point.

| can confirm that Invacare’s current manuals already contain clear guidance on securely
fastening the caps on humidifer bottles that may be added on as an accessory. As part of
our review following the inquest we have agreed to enhance the guidance provided.

We intend to do so by updating the manuals provided to customers such as Dolby Vivisol,
with the concentrator units.

We have not yet finalised the exact language that will be featured in the update, however
we anticipate a form of words similar to the following text would be added to the existing
warnings in the manuals:

Yes, you can.

Confirm that the humidifier cap is not cross threaded on the humidifier bottle.

Failure to properly install the humidifier bottle or other accessories to the
concentrator will impact the flow of oxygen.

This upate will be phased into all Invacare manuals within the next several months. As is our
usual practice, a technical update will also be sent to all customers in Europe to confirm that
our manuals have been updated.

| can confirm that Invacare have liaised with Dolby Vivisol directly in relation to the current
training and literature provided and the amendments they propose to make. Invacare have
also updated Dolby Vivisol on the amendments we intend to roll out.

Whilst noting that our literature, as supplied to the customer, will reference the fact that
failing to properly engage the cap to a humidifer may have an effect on oxygen flow, this
must be factored in alongside the key points that there may be other factors which affect
flow and that our equipment is not intended to be life sustaining.

| trust that | have provided the information required and that this was of assistance.

Yours faithfully

Managing Director

Invacare (UK) Limited

SALTER LABS

15 January 2015

FAO Martin Fleming, HM Assistant Coroner for Surrey
HM Coroner’s Court

Station Approach

Woking

Surrey

GU22 7AP

Inquest touching the death of Gaenor Moore
Regulation 28 Report — Action to Prevent Future Deaths

Dear Sir,

This letter constitutes Salter Labs’ reply to the Regulation 28 Report dated 24 November 2014 issued
further to the inquest touching the death of Gaenor Moore.

Firstly, Salter wishes to extend our sincere condolences to the family of Gaenor Moore; it is never easy to
lose a loved one regardless of the circumstances.

Secondly, we would like to reassure you that Salter Labs takes our responsibilities as medical device
manufacturers very seriously and are fully committed to patient safety. Upon learning of the incident via
notice of the inquest, we immediately requested the suspect E7600 bubble humidifier be returned or
otherwise made available to us so that we could examine it for manufacturing defects even though no
defects were suggested in the documentation we received. To date, the humidifier has not been returned
to Salter for analysis. We filed an initial Vigilance Report with the UK Medicines and Healthcare Products
Regulatory Agency (MHRA) promptly, and will provide an updated Vigilance Report to include information
obtained as a result of the inquest and corrective actions described here-in.

Three concerns were raised In Section 5 of the Regulation 28 Report:

1. The lack of oxygen flow to the nasal cannula as a result of the screw cap to the humidifier not
being properly engaged.

Background
Cross Threading Risk
We note the Coroner’s conclusion that the cap to the humidifier was not properly engaged at the
time of the engineer’s examination, and the Coroner's conclusion that it is “more likely than not

that the lack of oxygen made less than a minimal contribution to her death”. We believe that this
accurately reflects evidence heard at the inquest that this type of oxygen delivery system is not

100 W. SYCAMORE ROAD: ARVIN. CALIFORNIA 93203-2300
PHONE: 661-854-3166 FAX: 661-854-3850

intended as life sustaining, but is instead prescribed for supplementary oxygen and patient
comfort.

We would like to bring to your attention several points that weren’t necessarily relevant to the
inquest but speak to the potential for corrective actions.

Cross Threading Incidence

Difficulties with humidifier cross-threading are rare. Like all medical device companies, Salter
maintains a risk management file on our products in accordance with EN ISO 14971:2012. Salter
has manufactured over 16,700,000 bubble humidifiers with this lid design over the last four years.
During this time, we have received only one other report of potential cross threading, which was
unconfirmed (there was no patient injury in the other incident, which occurred in the USA). This
complaint rate equates to an overall cross-threading incident rate of only 0.12 Complaints per
Million (CPM).

Safety Valve

Each Salter bubble humidifier already includes a safety valve to detect blockages and leaks as

follows:

¢ If there is a downstream blockage in the system between the humidifier and the patient (such
as a kinked tube), pressure will build up in the humidifier and a safety valve will open to relieve
pressure and produce an audible whistle to notify the user - an alarm system warning of
blockages.

« The safety valve can also be used to check for leaks including, but not limited to, leaks caused
by cross-threading the lid. If the user or carer intentionally blocks the oxygen flow (which can
be done simply by pinching the tube) at a point past the humidifier outlet and the safety valve
does not open and whistle, it indicates there is a leak in the system.

The current Salter labeling on Salter 7600-series humidifiers provides a diagram and instructions
for how to test for leaks. It reads “To test for leaks: Turn on O2 source to 6 LPM and block outlet.
Humidifier should sound in 5 seconds or less. If not, check connections”.

Corrective Actions
Thread Design — Corrective Action Complete

As noted in the independent engineering report discussed at the Inquest, Salter bubble
humidifiers incorporate a double helix thread design. The current thread design was utilised
intentionally, to improve ease of use while also reducing the opportunity for cross-threading.

As a result of this incident and in light of the Coroner’s recommendation, Salter convened an

internal multi-disciplinary technical design review in December 2014 to evaluate the thread

design on several commercially available bubble humidifiers, including the Salter Labs 7600 series

bubble humidifier. The design review team determined that:

e The double-start thread significantly reduces the number of rotations necessary to secure the
lid to the bottle. Since hand rotations are difficult for individuals with reduced dexterity, this
design feature significantly improves ease of use of the humidifier for some users. The Salter

100 W. SYCAMORE ROAD « ARVIN, CALIFORNIA 93203-2300
PHONE: 661-854-3166 FAX: 661-854-3850

2.

humidifier required less rotation to secure the lid than any of the other humidifiers evaluated.
This is an important design consideration for the typical humidifier user or carer.

© Some of the other humidifiers evaluated utilise a finer thread pitch. The relatively course
thread pitch on the Salter humidifier makes cross-threading both less likely and more
noticeable to the user or carer.

The design review team concluded that the current Salter humidifier thread design is appropriate
for this application and that the risk associated with cross-threading has been reduced as far as
possible. The results of this review, together with the current overall cross-threading incident
rate of 0.12 CPM, have been documented in Salter’s humidifier risk management file.

Product Labeling — Corrective Action Pending

In addition to the current product labeling that advises users to check for leaks and provides

instructions on how to check for leaks (as described above), Salter will add two more statements

to the labeling in all languages:

e After the current instructions for adding water, we will add “Replace lid and check that it is
sealed properly” or equivalent.

¢ Before the current instructions to check for leaks, we will advise users why it is important that
they check for leaks by adding the phrase “Leaks may partially or fully reduce oxygen being
delivered to the patient’ or equivalent.

These labeling changes will be implemented for all product manufactured after 15 February 2015
(i.e., lot codes 021615 and later).

Absence of a visual or audible alarm on concentrator machine (product number INV-IRC5PO2AWN)
to indicate the loss of oxygen flow to the nasal cannula when the screw cap to the humidifier
(manufactured by Salter Labs) was tightened and cross threaded.

This concern is best addressed by the concentrator manufacturer cited in your report, Invacare
Rehabilitation. However, as we point out just above, the humidifier actually does have a blockage
warning system and a simple test for leaks. Further, though your concern references humidifiers
“manufactured by Salter Labs” specifically, we would like to point out that all brands of bubble
humidifiers compatible with the Invacare style of concentrator are similarly designed with a bottle
and screw-on lid, and have some risk of being cross-threaded.

Accompanying training and literature did not reference the implications to oxygen flow in the event
of failing to properly engage the screw cap to the humidifier.

This concern is best addressed by the equipment provider cited in your report, Dolby Vivisol. You will
recall that you heard oral evidence from Dolby Vivisol during the Inquest that they will be updating
their literature and training to make sure the risk of cross threading the humidifier lid is made even
more explicit. Additionally, we would like to note that Dolby Vivisol has accepted Salter Labs offer to
review the updated literature before finalising it. We will take this Opportunity to ensure that Dolby
Vivisol include reference to the safety valve as explained above.

100 W. SYCAMORE ROAD - ARVIN, CALIFORNIA 93203-2300
PHONE: 661-854-3166 FAX: 661-854-3850

Thank you for the opportunity to reply to your recommendations from the inquest. Salter bubble
humidifiers have a long and safe record of enhancing the comfort of patients undergoing supplementary
oxygen therapy, by preventing drying of the mucous membranes in the nose and mouth, ensuring
adequate hydration, and preventing increased viscosity of secretions. Salter continually monitors the use
of our devices in the field, and is constantly looking for ways to further enhance the design, manufacturing
and labelling of all our products. Please do not hesitate to contact me if you have any further questions
or concerns.

Regards,

Vice President, Quality and Regulatory Affairs
Salter Labs

100 W. SYCAMORE ROAD - ARVIN. CALIFORNIA 93203-2300
PHONE: 661-854-3166 FAX: 661-854-3850