Gaenor Moore

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 1 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 manufacture or design of the Equipment: When the Company receives an order physician to install home oxygen with patient we visit the patient's location, usually their own home or care home_ and conduct an installation. The installation process is comprised of conducting 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 as more general educational pieces of information explaining how the patient can safe whilst 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'$ 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 the from well stay using

DolbyVivISQL Home Respiratory Care "The lack of oxygen flow to the nasal cannula as result of the screw cap humidifier not properly engaged"; 2 "Absence of a visual or audible alarm on concentrator machine (product number INV-IRCSPOZAWN) 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 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 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) Absence of visual or audible alarm on concentrator machine (product number INV-IRCSPOZAWN) 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 Oifice: Monitor House, Kerse Road. Stirling FK7 7RZ being

DolbyvivIsQL Hame Respiratory Care The Company currently supplies the patient with 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 patient requires humidifier there is 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:
3.2 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 failure to properly fasten humidifier cap to its oxygen concentrator. The correspondence with Invacare is currently on-going, although 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.
3.3 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 Lid. Registered in Scotland No. 63902 Registered Ollice: Monitor House, Kerse Road. Stirling FK7 7RZ

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 24th 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 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 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 BHTA Pencoed Technology Park Pencoed Bridgend CF35 SAQ UK Tel: +44 (0)1656 776200 Fax: +44 (0)1656 77620/ wwW invacare CO.Uk Registered in Cardiff No. 5/78693 Yes; they

INVACAR Equipment use you can: Invacare' s concentrator unit is not intended as life sustaining equipment; as accepted in the evidence of and 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 manual and So are provided as matter of course to each of our customers: 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 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 off oxygen; also accepted in the evidence of at 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 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 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 engineer 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: Yes; - they They they spells

IMVACAR 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 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 SPOZAWN) 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'$ 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 1S08359, as required by the European Medical Devices Directives. Oxygen concentrators that comply with these standards are recognised as safe to operate 1S08359 set out requirements for manuals in respect of containing appropriate technical descriptions together with 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 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 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 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: 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 the 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; The proposed alarm would require additional lengthy wiring and connection points which may increase the potential for leaks and a5 a result, erroneous alarms, or the potential for wiring problems. There is then a greater risk of the user ignoring all/any alarm; Yes, point

INVACAR Yes,you can: 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); The proposed alarm would have to be as close as possible to the user which would as a result tether 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 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; note that the initial view expressed by 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 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 can confirm that Invacare'$ current manuals already contain clear guidance on securely fastening the caps on humidifer bottles that may be added 0n 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 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: put point. yet

INVACAI 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 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 humidifer may have an effect on oxygen flow, this must be factored in alongside the 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

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 VoU 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 ofthe Regulation 28 Report: The lack of oxygen flow to the nasal cannula as @ result of the screw cap to the humidifier not being properly engaged. Background Cross Threading Risk We note the Coroner'$ conclusion that the cap to the humidifier was not properly engaged at the time of the engineer' $ examination, and the Coroner' s conclusion that it is more likely than not that the lack of oxygen made less than @ 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 vears 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 asa 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 bv 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 02 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 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 Coroners 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: 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 Salter 100 Wv: SYCAMORE ROAD ARVIN_ CALIFORNIA 93203-2300 PHONE: 661-854-3166 FAX: 661-854-3850 The The The

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 thread pitch: The relatively course thread pitch on the Salter humidifier makes cross- ~threading both less likely ad 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' $ humidifier risk management file. Product Labeling Corrective Action Pending In addition to the current product labeling that advises users to check for leaks ad provides instructions on how to check for leaks (as described above), Salter will add two more statements to the labeling in all languages: 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 thev 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-IRCSPOZAWN) 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 vour report, Invacare Rehabilitation However; as we point out just above; the humidifier actually does have a blockage warning system ad 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 similarlv designed with a bottle and screw-on lid, and have some risk of cross-threaded:
3. Accompanving 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 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: 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 finer being Dolby We

Thank vou for the opportunity to reply to our 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 ad mouth, ensuring adequate hydration, and preventing increased viscosity of secretions. Salter continually monitors the use ofour 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