Report evidence summary
Stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised. 18
Salter Labs Ensure updated equipment-provider literature includes reference to the humidifier safety valve.
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Salter Labs Add multilingual labeling instructing users to check that the lid is properly sealed and explaining that leaks can reduce oxygen delivery.
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Salter Labs File an updated Vigilance Report incorporating information from the inquest and the described corrective actions.
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Salter Labs Continue monitoring field use of devices and seeking further improvements to product design, manufacturing and labeling.
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Salter Labs Complete a multidisciplinary technical review of the humidifier thread design and document its findings in the risk management file.
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Dolby Vivisol Communicate literature amendments to relevant staff and reinforce them during future patient and carer installation training.
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Dolby Vivisol Submit finalized literature amendments to NHS contract managers for approval.
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Dolby Vivisol Liaise with Salter Labs about revised humidifier safety instructions and warnings about leaks affecting oxygen supply.
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Dolby Vivisol Review and update company instructions and training materials after receiving manufacturers’ finalized amendments.
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Dolby Vivisol Liaise with Invacare about revised instructions warning of oxygen-flow effects when humidifier caps are improperly fastened.
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Dolby Vivisol Modify humidifier literature to explain incorrect connection risks and emphasise confirming oxygen flow from the nasal cannula.
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Dolby Vivisol Distribute approved updated literature to current and future equipment users, highlighting amendments for current humidifier patients.
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Invacare (UK) Limited Remove references to supplying humidifier bottles from concentrator manuals.
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Invacare (UK) Limited Send European customers a technical update confirming that the manuals have been updated.
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Invacare (UK) Limited Provide guidance in current manuals on securely fastening humidifier bottle caps.
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Invacare (UK) Limited Update customer manuals with warnings that cross-threaded or improperly installed humidifier bottles and accessories can affect oxygen flow.
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Invacare (UK) Limited Assess whether an alarm can detect oxygen-flow loss caused by an improperly engaged humidifier cap.
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Invacare (UK) Limited Phase the updated warning into all Invacare manuals over the next several months.
View source Respondent positions A position is what a recipient says about a concern when it does not describe a specific action. 11
Salter Labs The equipment provider is responsible for updating training and literature about the implications of improperly engaging the humidifier cap.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source
Salter Labs The current humidifier thread design is appropriate and has reduced cross-threading risk as far as possible.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed. View source
Salter Labs The humidifier’s existing safety valve and leak-test instructions provide warnings for blockages and leaks, including cross-threading-related leaks.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed. View source
Salter Labs The concentrator manufacturer is responsible for addressing the absence of a visual or audible alarm for lost oxygen flow.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source
Dolby Vivisol Equipment manufacture and design concerns should be addressed by the relevant manufacturers, Invacare and Salter Labs.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source
Dolby Vivisol Equipment manufacture and design concerns fall outside the company’s functions, so it cannot respond to them.
Outside remitThe respondent said that this matter was outside its role or authority. View source
Invacare (UK) Limited Humidifier bottles are supplied by others, so Salter Labs should directly address concerns about their design and operation.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source
Invacare (UK) Limited Current and recent manuals do not state that concentrator units are supplied with humidifier bottles.
Disputes the concernThe respondent disagreed with part of the concern or the basis for it. View source
Invacare (UK) Limited An alarm detecting oxygen loss at the humidifier would be technically complex and introduce unacceptable risks and inconvenience without sufficient benefit.
Unable to actThe respondent said that a constraint prevented them from taking the relevant action. View source
Invacare (UK) Limited Suppliers such as Dolby Vivisol are responsible for end-user training and literature, so Dolby Vivisol should lead this work.
Redirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action. View source
Invacare (UK) Limited Existing alarms detect relevant concentrator faults, comply with applicable standards, and are considered sufficient without additional alarms.
Existing arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed. View source
× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
PFD Monitor interpretation Failure to properly engage the humidifier screw cap, causing loss of oxygen flow to the nasal cannula
Wider context from the report “• The lack of oxygen flow to the nasal cannula as a result of the screw cap to the humidifier not being properly engaged.
• 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.
• 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
PFD Monitor interpretation Absence of a visual or audible alarm indicating loss of oxygen flow to the nasal cannula
Wider context from the report “• The lack of oxygen flow to the nasal cannula as a result of the screw cap to the humidifier not being properly engaged.
• 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.
• 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.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.
PFD Monitor interpretation Failure of accompanying training and literature to explain the oxygen-flow implications of improper humidifier screw-cap engagement
Wider context from the report “• The lack of oxygen flow to the nasal cannula as a result of the screw cap to the humidifier not being properly engaged.
• 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.
• 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.
” Open source report
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Ensure updated equipment-provider literature includes reference to the humidifier safety valve.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Salter-Labs
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Add multilingual labeling instructing users to check that the lid is properly sealed and explaining that leaks can reduce oxygen delivery.
Verbatim wording from the response “Product Labeling – Corrective Action Pending” Source location 2014-0512-Response-by-Salter-Labs
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation File an updated Vigilance Report incorporating information from the inquest and the described corrective actions.
Verbatim wording from the response “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 herein.” Source location 2014-0512-Response-by-Salter-Labs
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Continue monitoring field use of devices and seeking further improvements to product design, manufacturing and labeling.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Salter-Labs
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Complete a multidisciplinary technical review of the humidifier thread design and document its findings in the risk management file.
Verbatim wording from the response “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 Bals 7600 series bubble humidifier. The design review team determined that:” Source location 2014-0512-Response-by-Salter-Labs
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Communicate literature amendments to relevant staff and reinforce them during future patient and carer installation training.
Verbatim wording from the response “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 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.” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Submit finalized literature amendments to NHS contract managers for approval.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Liaise with Salter Labs about revised humidifier safety instructions and warnings about leaks affecting oxygen supply.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Review and update company instructions and training materials after receiving manufacturers’ finalized amendments.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Liaise with Invacare about revised instructions warning of oxygen-flow effects when humidifier caps are improperly fastened.
Verbatim wording from the response “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 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.” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Modify humidifier literature to explain incorrect connection risks and emphasise confirming oxygen flow from the nasal cannula.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Distribute approved updated literature to current and future equipment users, highlighting amendments for current humidifier patients.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Remove references to supplying humidifier bottles from concentrator manuals.
Verbatim wording from the response “At the inquest, expert engineer ████████ referred in evidence to an Invacare manual. This manual referred to our concentrator units being supplied with humidifier bottles. I am not aware of which version of the manual was relied upon in evidence however I can report that enquiries were made following the inquest and I confirm that our manuals have not referred to humidifier 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.” Source location 2014-0512-Response-by-Invacare
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Send European customers a technical update confirming that the manuals have been updated.
Verbatim wording from the response “This update 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.” Source location 2014-0512-Response-by-Invacare
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Provide guidance in current manuals on securely fastening humidifier bottle caps.
Verbatim wording from the response “I can confirm that Invacare’s current manuals already contain clear guidance on securely fastening the caps on humidifier 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.” Source location 2014-0512-Response-by-Invacare
Open published response
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Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Update customer manuals with warnings that cross-threaded or improperly installed humidifier bottles and accessories can affect oxygen flow.
Verbatim wording from the response “I can confirm that Invacare’s current manuals already contain clear guidance on securely fastening the caps on humidifier 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.” Source location 2014-0512-Response-by-Invacare
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Assess whether an alarm can detect oxygen-flow loss caused by an improperly engaged humidifier cap.
Verbatim wording from the response “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:” Source location 2014-0512-Response-by-Invacare
Open published response
×
Source evidence
How this respondent action was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Phase the updated warning into all Invacare manuals over the next several months.
Verbatim wording from the response “This update 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.” Source location 2014-0512-Response-by-Invacare
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The equipment provider is responsible for updating training and literature about the implications of improperly engaging the humidifier cap.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Salter-Labs
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The current humidifier thread design is appropriate and has reduced cross-threading risk as far as possible.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Salter-Labs
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The humidifier’s existing safety valve and leak-test instructions provide warnings for blockages and leaks, including cross-threading-related leaks.
Verbatim wording from the response “2. Absence of a visual or audible alarm on concentrator machine (product number INV-IRCSPO2AWN) 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.” Source location 2014-0512-Response-by-Salter-Labs
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation The concentrator manufacturer is responsible for addressing the absence of a visual or audible alarm for lost oxygen flow.
Verbatim wording from the response “2. Absence of a visual or audible alarm on concentrator machine (product number INV-IRCSPO2AWN) 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.” Source location 2014-0512-Response-by-Salter-Labs
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Equipment manufacture and design concerns should be addressed by the relevant manufacturers, Invacare and Salter Labs.
Verbatim wording from the response “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).” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Equipment manufacture and design concerns fall outside the company’s functions, so it cannot respond to them.
Verbatim wording from the response “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).” Source location 2014-0512-Response-by-Dolby-Vivsol
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Humidifier bottles are supplied by others, so Salter Labs should directly address concerns about their design and operation.
Verbatim wording from the response “Further, I can confirm that we do not produce or provide humidifier 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.” Source location 2014-0512-Response-by-Invacare
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Current and recent manuals do not state that concentrator units are supplied with humidifier bottles.
Verbatim wording from the response “At the inquest, expert engineer ████████ referred in evidence to an Invacare manual. This manual referred to our concentrator units being supplied with humidifier bottles. I am not aware of which version of the manual was relied upon in evidence however I can report that enquiries were made following the inquest and I confirm that our manuals have not referred to humidifier 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.” Source location 2014-0512-Response-by-Invacare
Open published response
×
Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation An alarm detecting oxygen loss at the humidifier would be technically complex and introduce unacceptable risks and inconvenience without sufficient benefit.
Verbatim wording from the response “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:” Source location 2014-0512-Response-by-Invacare
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Suppliers such as Dolby Vivisol are responsible for end-user training and literature, so Dolby Vivisol should lead this work.
Verbatim wording from the response “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 humidifier 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.” Source location 2014-0512-Response-by-Invacare
Open published response
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Source evidence
How this respondent position was interpreted
PFD Monitor created a concise, searchable interpretation from the published response wording shown below.
PFD Monitor interpretation Existing alarms detect relevant concentrator faults, comply with applicable standards, and are considered sufficient without additional alarms.
Verbatim wording from the response “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.” Source location 2014-0512-Response-by-Invacare
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