Recurring concern

Unreliable oxygen humidifier safety controls

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First reported 24 Nov 2014•Latest report 3 Feb 2017

Definition

What this concern includes

Includes failures of controls specifically dedicated to oxygen humidifier safety, including operation and temperature checks, connection and engagement, flow verification, alarms, user instructions, handover checks and response to humidifier malfunction.

Not included

  • Excludes general oxygen prescribing, supply, administration, supervision or clinical-monitoring failures where the oxygen humidifier is not the deficient control.
  • Excludes oxygen-concentrator, portable-cylinder and other oxygen-equipment failures unless they directly concern the oxygen humidifier safety process.
  • Excludes generic training, documentation or communication deficiencies unless they directly impair safe oxygen humidifier operation or monitoring.
  • Excludes failures occurring after oxygen flow has been reliably established when the remaining concern is clinical treatment or monitoring unrelated to the humidifier.
Reports
2

Distinct published reports

Individual concerns
3

A report can raise multiple concerns

Date range
2014–2017

First to latest report issue date

Stated actions
13

Described in published responses

Reports over time

Reports over time

Reports about this concern issued each year.

* 2026 is projected from reports observed to 7 Sep 2026.

Most frequent recipients

Most frequent recipients

Reports about this concern sent to each recipient.

Care Quality Commission1
Dolby Vivisol1
Fisher & Paykel Healthcare Limited1
HCA Healthcare UK1
Invacare Limited1
London Bridge Hospital1
Nursing and Midwifery Council1
Salter Labs1

Concerns and responses across reports

Only concerns grouped under this recurring concern are included. Select any concern, action or position to view the source wording.

  1. London Inner (South)

    AI-generated summary

    ROBERT ENTENMAN · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Robert Entenman was an intubated intensive care patient whose humidifier was turned off from around 12.00pm on 22 May 2015 until 6.00am on 23 May 2015. A mucus plug blocked his endotracheal tube, leading to cardiac arrest shortly after 6.00am; he died on 30 May 2015. Concerns included failures to observe that the humidifier was off, the absence of an alarm on the humidifier, delays in identifying and replacing the blocked tube, and possible delays in communicating suction difficulties to doctors.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    PFD Monitor interpretation

    Failure to monitor humidifier operation and temperature

    Wider context from the report

    “(1) Three nurses cared for Mr Entenman between 12.00pm on 22 May 2015 and 6.00am on 23 May 2015. During that time they did not observe that the humidifier had been turned off, either handovers that took place between them or each hour when they should have recorded the temperature reading from the humidifier. ”

    Source location

    ROBERT ENTENMAN · Prevention of Future Deaths report
    Page 2 · concerns

    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

    Investigate the nursing-care concerns in accordance with statutory functions.

    Verbatim wording from the response

    “We are aware of the particular issues raised about the registered nurse who reviewed Mr Entenman in the time leading up to his death. We are currently investigating this matter and are considering the concerns in accordance with our statutory functions.”

    Source location

    2017-0011-Response-by-NMC
    Page 1 · response
    Published 19 February 2017

    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

    Action on concern 1 is assigned to the NMC; LBH considers itself not required to act because it is not responsible.

    Verbatim wording from the response

    “Concern numbered (1) indicates that the Nursing and Midwifery Council (“NMC”) has the power to take action. LBH is not required to take action having already satisfied the Coroner that it is not responsible for addressing this concern.”

    Source location

    2017-0011-Response-by-London-Bridge-Hospital
    Page 2 · response
    Published 19 February 2017

    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 completed RCA action plan was considered sufficient to mitigate recurrence risk, with the planned actions carried out.

    Verbatim wording from the response

    “The CQC requested a final copy of the RCA document as part of the inspection process in 2016, and received this on 28 October 2016. The document had been completed on 30 October 2015. It set out the background to the incident, the possible causes and a proposed action plan to prevent the re-occurrence of similar incidents. The CQC was satisfied that the actions set out in the RCA would be sufficient to mitigate the risk of re-occurrence and, further, that those actions had been carried out.”

    Source location

    2017-0011-Response-by-Care-Quality-Commission
    Page 2 · response
    Published 19 February 2017

    Open published response
  2. Surrey

    AI-generated summary

    Gaenor Moore · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Gaenor Moore, who had chronic obstructive pulmonary disease and required an oxygen concentrator with humidifier, became breathless, deteriorated and died at her residential care home after the humidifier cap was not properly engaged, preventing oxygen flow to her nasal cannula. Concerns included the absence of a visual or audible alarm to indicate loss of oxygen flow and training and literature that did not explain the implications of failing to properly engage the humidifier cap.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    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. ”

    Source location

    Gaenor Moore · Prevention of Future Deaths report
    Page 2 · concerns

    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below.

    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. ”

    Source location

    Gaenor Moore · Prevention of Future Deaths report
    Page 2 · concerns

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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 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 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

    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

    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

    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

    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
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Data last updated 7 September 2026