PFD report

Gaenor Moore · Prevention of Future Deaths report

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Issued 24 Nov 2014•Surrey

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
3

Raised in this report

Recipients
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
18

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

Open published report

Concerns and recipient responses

Select any concern, action or position to view the source wording.

Concerns raised3

  1. Failure to properly engage the humidifier screw cap, causing loss of oxygen flow to the nasal cannula
    Part of recurring concern: Unreliable oxygen humidifier safety controlsPart of recurring concern: Unsafe provision of oxygen therapy
  2. Absence of a visual or audible alarm indicating loss of oxygen flow to the nasal cannula
    Part of recurring concern: Unreliable alarm controls for oxygen therapyPart of recurring concern: Unreliable oxygen concentrator safety controls
  3. Failure of accompanying training and literature to explain the oxygen-flow implications of improper humidifier screw-cap engagement
    Part of recurring concern: Unreliable oxygen humidifier safety controls
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.13

  1. Action

    Ensure updated equipment-provider literature includes reference to the humidifier safety valve.

    Stated by Salter LabsStated plannedThe respondent said that this action was planned when they made their response on 24 November 2014.
  2. Action

    Add multilingual labeling instructing users to check that the lid is properly sealed and explaining that leaks can reduce oxygen delivery.

    Stated by Salter LabsStated plannedThe respondent said that this action was planned when they made their response on 24 November 2014.
  3. Action

    Complete a multidisciplinary technical review of the humidifier thread design and document its findings in the risk management file.

    Stated by Salter LabsStated completedThe respondent said that this action was complete when they made their response on 24 November 2014.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.10

  1. Position

    The equipment provider is responsible for updating training and literature about the implications of improperly engaging the humidifier cap.

    Stated by Salter LabsRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

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. ”

Is this part of a recurring concern?

Yes — Unreliable oxygen humidifier safety controls; Unsafe provision of oxygen therapy.

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. ”

Is this part of a recurring concern?

Yes — Unreliable alarm controls for oxygen therapy; Unreliable oxygen concentrator safety controls.

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. ”

Is this part of a recurring concern?

Yes — Unreliable oxygen humidifier safety controls.

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
Page 3 · response
Published 24 November 2014

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

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
Page 3 · response
Published 24 November 2014

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

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
Page 2 · response
Published 24 November 2014

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

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
Page 3 · response
Published 24 November 2014

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

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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

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
Page 4 · response
Published 24 November 2014

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

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
Page 4 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 5 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 2 · response
Published 24 November 2014

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
Page 2 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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
Page 3 · response
Published 24 November 2014

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

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
Page 4 · response
Published 24 November 2014

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

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
Page 3 · response
Published 24 November 2014

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.5

  1. 1

    File an updated Vigilance Report incorporating information from the inquest and the described corrective actions.

    Stated by Salter LabsStated plannedThe respondent said that this action was planned when they made their response on 24 November 2014.
  2. 2

    Continue monitoring field use of devices and seeking further improvements to product design, manufacturing and labeling.

    Stated by Salter LabsStated in progressThe respondent said that this action was in progress when they made their response on 24 November 2014.
  3. 3

    Liaise with Salter Labs about revised humidifier safety instructions and warnings about leaks affecting oxygen supply.

    Stated by Dolby VivisolStated in progressThe respondent said that this action was in progress when they made their response on 24 November 2014.
  4. 4

    Remove references to supplying humidifier bottles from concentrator manuals.

    Stated by Invacare (UK) LimitedStated completedThe respondent said that this action was complete when they made their response on 24 November 2014.
  5. 5

    Send European customers a technical update confirming that the manuals have been updated.

    Stated by Invacare (UK) LimitedStated plannedThe respondent said that this action was planned when they made their response on 24 November 2014.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.1

  1. 1

    Current and recent manuals do not state that concentrator units are supplied with humidifier bottles.

    Stated by Invacare (UK) LimitedDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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
Page 1 · response
Published 24 November 2014

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

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
Page 4 · response
Published 24 November 2014

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 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
Page 3 · response
Published 24 November 2014

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
Page 2 · response
Published 24 November 2014

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

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
Page 5 · response
Published 24 November 2014

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
Page 2 · response
Published 24 November 2014

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026