PFD report

PATRICK NEIL WOODS · Prevention of Future Deaths report

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Issued 19 Jun 2017•Bedfordshire and Luton

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
4

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
14

Described in responses

Recipients and published responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

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

Concerns raised4

  1. Lack of knowledge of the equipment portfolio
  2. Ineffective training on equipment
  3. Failure to identify potentially dangerous equipment
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.7

  1. Action

    Make a training video specifically addressing ACGO-switch use for introductory and refresher training.

    Stated by Draeger Medical UK LimitedStated plannedThe respondent said that this action was planned when they made their response on 19 June 2017.
  2. Action

    Update training materials to cover ACGO and COSY operation, ventilation modes, fresh-gas routing, monitored parameters, and hypoxic-mixture risks.

    Stated by Draeger Medical UK LimitedStated completedThe respondent said that this action was complete when they made their response on 19 June 2017.
  3. Action

    Contact UK Fabius customers to arrange Draeger site visits addressing concerns and further training needs within 16 weeks after the Field Safety Notice.

    Stated by Draeger Medical UK LimitedStated plannedThe respondent said that this action was planned when they made their response on 19 June 2017.

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

Lack of knowledge of the equipment portfolio

Wider context from the report

“(1) The extent of the equipment portfolio held by the Hospital seemed to be unknown (2) Without the knowledge of the equipment held, no potentially dangerous equipment can be identified (3) Without the knowledge that there is equipment that could potentially kill a patient, no risk assessment can be undertaken (4) Without a risk assessment, no action can be taken to prevent further injury to patients or fatalities ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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

Ineffective training on equipment

Wider context from the report

“(1) The evidence of 4 clinicians at the inquest would suggest that the training by Dräger was not effective. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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 to identify potentially dangerous equipment

Wider context from the report

“(1) The extent of the equipment portfolio held by the Hospital seemed to be unknown (2) Without the knowledge of the equipment held, no potentially dangerous equipment can be identified (3) Without the knowledge that there is equipment that could potentially kill a patient, no risk assessment can be undertaken (4) Without a risk assessment, no action can be taken to prevent further injury to patients or fatalities ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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 to undertake risk assessments for equipment that could potentially kill a patient

Wider context from the report

“(1) The extent of the equipment portfolio held by the Hospital seemed to be unknown (2) Without the knowledge of the equipment held, no potentially dangerous equipment can be identified (3) Without the knowledge that there is equipment that could potentially kill a patient, no risk assessment can be undertaken (4) Without a risk assessment, no action can be taken to prevent further injury to patients or fatalities ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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

Make a training video specifically addressing ACGO-switch use for introductory and refresher training.

Verbatim wording from the response

“5. In further pursuit of achieving the objectives identified above, Draeger intends also to take the following steps:”

Source location

2017-0434-Response-by-Draeger-Medical-UK-Limited
Page 4 · response
Published 19 June 2017

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 training materials to cover ACGO and COSY operation, ventilation modes, fresh-gas routing, monitored parameters, and hypoxic-mixture risks.

Verbatim wording from the response

“4. Draeger recognises as a crucial priority the importance of optimising patient safety through optimising clinician competence regards the functionality of the machine. With those objectives in mind, Draeger has decided to take the following steps:”

Source location

2017-0434-Response-by-Draeger-Medical-UK-Limited
Page 2 · response
Published 19 June 2017

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

Contact UK Fabius customers to arrange Draeger site visits addressing concerns and further training needs within 16 weeks after the Field Safety Notice.

Verbatim wording from the response

“b. The circulation worldwide of a Field Safety Notice (“FSN”) to hospitals for circulation amongst their anaesthetic departments drawing attention to the principles applicable to re-breathing circuit systems. Draeger will also send a copy of the FSN to electrical and biomedical engineering (EBME) bodies within each hospital within the UK to whom the FSN is sent. Draeger anticipates that the distribution of the FSN will begin from October 2017. Draeger will follow up the circulation of its FSN within the UK by seeking confirmation of receipt.”

Source location

2017-0434-Response-by-Draeger-Medical-UK-Limited
Page 3 · response
Published 19 June 2017

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 each clinical area, cross-check equipment sub-lists, and update the Trust master equipment log to create a complete and current equipment register.

Verbatim wording from the response

“Further action | Timescale There is to be a review of each clinical area where an item of equipment is used, to ensure that the Trust has a complete and up to date “master” log of the equipment held.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 5 · response
Published 19 June 2017

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

Require clinical directors and matrons to risk-assess identified equipment, review unused functionality, and report findings through the Medical Equipment Group.

Verbatim wording from the response

“By the end of October 2017, a request will be sent to the Clinical Director and Matron of each clinical area which has a “sub list”, who will then be responsible for undertaking a risk assessment of the identified equipment in their area and to review the unused functionality of said equipment / device. | The risk assessments must take place by the end of January 2018.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 6 · response
Published 19 June 2017

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

Introduce TCA checks covering equipment training, machine checks and alarm reviews within routine anaesthetic practice and pre-operative huddles.

Verbatim wording from the response

“Notices have been placed in each anaesthetic room to remind anaesthetists of the importance of ensuring they have received training on all pieces of equipment they are going to use, that they have checked the anaesthetic machine, and that they have reviewed the alarm settings. This TCA (Trained / Checked Machine / Alarms) methodology will become part of the routine practice of anaesthesia at the Luton & Dunstable Hospital, and will become part of the pre-operative huddle that occurs before the start of every list, including emergencies.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 2 · response
Published 19 June 2017

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

Implement a procedure to record new equipment on master and area sub-lists, maintain both lists, obtain procurement exception reports, and review their accuracy regularly.

Verbatim wording from the response

“From October 2017 the Trust will implement a new procedure whereby:”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 6 · response
Published 19 June 2017

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.7

  1. 1

    Regularly review performance and user-information findings at Competence Board level.

    Stated by Draeger Medical UK LimitedStated plannedThe respondent said that this action was planned when they made their response on 19 June 2017.
  2. 2

    Continuously review performance data and feedback from hospitals and individual users.

    Stated by Draeger Medical UK LimitedStated plannedThe respondent said that this action was planned when they made their response on 19 June 2017.
  3. 3

    Circulate a Field Safety Notice to hospitals and relevant UK hospital engineering bodies on re-breathing circuit principles, then seek UK receipt confirmations.

    Stated by Draeger Medical UK LimitedStated plannedThe respondent said that this action was planned when they made their response on 19 June 2017.
  4. 4

    Communicate default alarm limits and instruct anaesthetists and operating department practitioners to review and adjust them for patients requiring different settings.

    Stated by Bedfordshire Hospitals NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 19 June 2017.
  5. 5

    Take forward engagement with AAGBI to establish working practice that applies monitoring guidance appropriately in emergencies.

    Stated by Bedfordshire Hospitals NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 19 June 2017.
  6. 6

    Apply agreed safe default alarm limits retrospectively to current anaesthetic machines and prospectively before future machines enter clinical use.

    Stated by Bedfordshire Hospitals NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 19 June 2017.
  7. 7

    Circulate the highlighted AAGBI monitoring guidance and inquest concerns to all anaesthetists and operating department practitioners.

    Stated by Bedfordshire Hospitals NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 19 June 2017.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.4

  1. 1

    In emergencies, staff may be unable to predict appropriate alarm settings beforehand, so treatment may begin using defaults and adjustments occur during the case.

    Stated by Bedfordshire Hospitals NHS Foundation TrustUnable to actThe respondent said that a constraint prevented them from taking the relevant action.
  2. 2

    Drager, rather than the Trust, should review the Tiro’s potentially misleading oxygen sensor failure message and related manufacturing issue.

    Stated by Bedfordshire Hospitals NHS Foundation TrustRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.
  3. 3

    The agreed default alarm settings are considered acceptably safe for most fit, elective adult patients, with adjustment reserved for other cases.

    Stated by Bedfordshire Hospitals NHS Foundation TrustExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.
  4. 4

    The Trust cannot address equipment manufacturing issues and therefore cannot itself take action to correct the Tiro’s oxygen sensor alert behaviour.

    Stated by Bedfordshire Hospitals NHS Foundation TrustUnable to actThe respondent said that a constraint prevented them from taking the relevant action.

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

Regularly review performance and user-information findings at Competence Board level.

Verbatim wording from the response

“5. In further pursuit of achieving the objectives identified above, Draeger intends also to take the following steps:”

Source location

2017-0434-Response-by-Draeger-Medical-UK-Limited
Page 4 · response
Published 19 June 2017

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

Continuously review performance data and feedback from hospitals and individual users.

Verbatim wording from the response

“5. In further pursuit of achieving the objectives identified above, Draeger intends also to take the following steps:”

Source location

2017-0434-Response-by-Draeger-Medical-UK-Limited
Page 4 · response
Published 19 June 2017

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

Circulate a Field Safety Notice to hospitals and relevant UK hospital engineering bodies on re-breathing circuit principles, then seek UK receipt confirmations.

Verbatim wording from the response

“b. The circulation worldwide of a Field Safety Notice (“FSN”) to hospitals for circulation amongst their anaesthetic departments drawing attention to the principles applicable to re-breathing circuit systems. Draeger will also send a copy of the FSN to electrical and biomedical engineering (EBME) bodies within each hospital within the UK to whom the FSN is sent. Draeger anticipates that the distribution of the FSN will begin from October 2017. Draeger will follow up the circulation of its FSN within the UK by seeking confirmation of receipt.”

Source location

2017-0434-Response-by-Draeger-Medical-UK-Limited
Page 3 · response
Published 19 June 2017

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 default alarm limits and instruct anaesthetists and operating department practitioners to review and adjust them for patients requiring different settings.

Verbatim wording from the response

“The default alarm settings have been agreed by the anaesthetists and operating department practitioners as providing acceptable safety for the majority of elective adult patients who are fit and well. We have highlighted this fact in our communication with anaesthetists and ODP’s, and advised of the need to review alarm limits and set appropriate alarm limit values for all other cases.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 2 · response
Published 19 June 2017

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

Take forward engagement with AAGBI to establish working practice that applies monitoring guidance appropriately in emergencies.

Verbatim wording from the response

“The Trust has written to AAGBI about this separately, to ensure that there is no conflict between the guidance and emergency situations, and if necessary to seek their assistance on ensuring there is a working practice within the Trust that adheres to the guidance.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 3 · response
Published 19 June 2017

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

Apply agreed safe default alarm limits retrospectively to current anaesthetic machines and prospectively before future machines enter clinical use.

Verbatim wording from the response

“Every anaesthetic machine and monitor is configured with default alarms by the manufacturer prior to delivery of the machine to the Trust. As part of the commissioning of the machine, the settings of these default alarms are reviewed on behalf of the Trust by the Clinical Director for Anaesthetics to ensure they are fit for purpose. Since this incident, the default alarm settings have been discussed within the anaesthetic and operating department practitioners’ forums, and the Trust has agreed a Trust default setting for each variable, which have been applied retrospectively to all machines currently in use from 21 July 2017, and will be applied prospectively to all future machines before they are deployed for clinical use.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 1 · response
Published 19 June 2017

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

Circulate the highlighted AAGBI monitoring guidance and inquest concerns to all anaesthetists and operating department practitioners.

Verbatim wording from the response

“The AAGBI guidelines “Recommendations for Standards of Monitoring During Anaesthesia and Recovery December 2015”¹, with the relevant sections highlighted, have been circulated to all anaesthetists and Operating Department Practitioner’s by the Medical Director with an email² outlining the outcome of the inquest, and the concerns the Coroner raised.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 2 · response
Published 19 June 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

In emergencies, staff may be unable to predict appropriate alarm settings beforehand, so treatment may begin using defaults and adjustments occur during the case.

Verbatim wording from the response

“In an emergency setting, such as was the case of Mr Woods, the anaesthetist may be actively involved in treating the patient while transporting them to the theatre. As such, there will be scenarios where it may not be possible for an Operating Department Practitioner to be able to predict what alarm settings might be appropriate for such cases. Under such circumstances, the case may have to commence with the default alarm settings, and fine tuning of the alarm limits may need to take place during the case.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 3 · response
Published 19 June 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

Drager, rather than the Trust, should review the Tiro’s potentially misleading oxygen sensor failure message and related manufacturing issue.

Verbatim wording from the response

“Although the Trust is not able to take action in respect of manufacturing issues, the Trust considers that this is something which Drager should review and we would invite the coroner to consider the same when reviewing Drager’s PFD responses. For example, had that message not been displayed in this case, it is quite possible that there would have been earlier investigation of the low FiO2 because the low FiO2 alarm would not have been disregarded, or the decision to switch to an alternative oxygen source and mechanism of ventilation might have been made earlier.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 2 · response
Published 19 June 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 agreed default alarm settings are considered acceptably safe for most fit, elective adult patients, with adjustment reserved for other cases.

Verbatim wording from the response

“The default alarm settings have been agreed by the anaesthetists and operating department practitioners as providing acceptable safety for the majority of elective adult patients who are fit and well. We have highlighted this fact in our communication with anaesthetists and ODP’s, and advised of the need to review alarm limits and set appropriate alarm limit values for all other cases.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 2 · response
Published 19 June 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 Trust cannot address equipment manufacturing issues and therefore cannot itself take action to correct the Tiro’s oxygen sensor alert behaviour.

Verbatim wording from the response

“Although the Trust is not able to take action in respect of manufacturing issues, the Trust considers that this is something which Drager should review and we would invite the coroner to consider the same when reviewing Drager’s PFD responses. For example, had that message not been displayed in this case, it is quite possible that there would have been earlier investigation of the low FiO2 because the low FiO2 alarm would not have been disregarded, or the decision to switch to an alternative oxygen source and mechanism of ventilation might have been made earlier.”

Source location

2017-0434-Response-by-Luton-Dunstable-University-Hospital
Page 2 · response
Published 19 June 2017

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