PFD report

Kay Michelle Sheard · Prevention of Future Deaths report

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Issued 21 Dec 2015•North Wales (East and Central)

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.

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Concerns
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
4

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

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Concerns raised1

  1. Failure to set pulse oximeter alarm levels to reflect individual patients’ baseline oxygen saturations
    Part of recurring concern: Unreliable alarm controls for oxygen therapyPart of recurring concern: Unreliable monitoring of oxygen saturation during clinical carePart of recurring concern: Unreliable provision, reliability and use of pulse oximetry
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.3

  1. Action

    Raise pulse oximeter alarm-setting issues at Welsh and UK level through the MHRA.

    Stated by Betsi Cadwaladr University LHBStated plannedThe respondent said that this action was planned when they made their response on 21 December 2015.
  2. Action

    Check pulse oximeter alarm settings across approximately 1,200 devices.

    Stated by Betsi Cadwaladr University LHBStated completedThe respondent said that this action was complete when they made their response on 21 December 2015.
  3. Action

    Scope an action plan addressing pulse oximeter alarm-level safety.

    Stated by Betsi Cadwaladr University LHBStated completedThe respondent said that this action was complete when they made their response on 21 December 2015.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    Some pulse oximetry alarm-setting issues concern manufacturers and should be addressed through Wales- and UK-level channels, including the MHRA.

    Stated by Betsi Cadwaladr University LHBRedirects 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 set pulse oximeter alarm levels to reflect individual patients’ baseline oxygen saturations

Wider context from the report

“During the procedure the Deceased’s oxygen saturations were being monitored by a pulse oximeter for which I was advised that the alarm settings are routinely set at 85%. However all evidence indicated that it was the actual level of reading which would be significant for a patient but rather the amount by which saturations had dropped from the patient’s normal base level. Notwithstanding this, the evidence indicated that this would not be taken into account when fixing an alarm setting level and I am therefore concerned that there exists a potential risk to patients which could be reduced or eliminated by ensuring that the alarm level correctly reflects the individual patient’s condition. ”

Is this part of a recurring concern?

Yes — Unreliable alarm controls for oxygen therapy; Unreliable monitoring of oxygen saturation during clinical care; Unreliable provision, reliability and use of pulse oximetry.

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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

Raise pulse oximeter alarm-setting issues at Welsh and UK level through the MHRA.

Verbatim wording from the response

“A number of national and international bodies have produced guidelines on pulse oximetry. The Health Board has a significant amount of work to do on this issue, noting that pulse oximetry is used so widely, by so many different staff, in different clinical situations. However, our inquiries indicate that this issue also extends beyond the Health Board to the manufacturers, who install default alarm levels in their products, and the extent to which they support and facilitate user adjustment of alarm levels. Accordingly there are likely to be issues to be considered beyond BCU Health Board, and we will raise these both at Wales level, and at UK level through the MHRA (Medicines and Healthcare products Regulatory Agency).”

Source location

Kay-Sheard-Response
Page 1 · response
Published 21 December 2015

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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

Check pulse oximeter alarm settings across approximately 1,200 devices.

Verbatim wording from the response

“Since receiving the report BCU has done a significant amount of work in reviewing device holdings, checking device settings, and scoping the Action Plan for an inventory of approximately 1200 devices of varying complexity across the Health Board.”

Source location

Kay-Sheard-Response
Page 1 · response
Published 21 December 2015

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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

Scope an action plan addressing pulse oximeter alarm-level safety.

Verbatim wording from the response

“Since receiving the report BCU has done a significant amount of work in reviewing device holdings, checking device settings, and scoping the Action Plan for an inventory of approximately 1200 devices of varying complexity across the Health Board.”

Source location

Kay-Sheard-Response
Page 1 · response
Published 21 December 2015

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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

Some pulse oximetry alarm-setting issues concern manufacturers and should be addressed through Wales- and UK-level channels, including the MHRA.

Verbatim wording from the response

“A number of national and international bodies have produced guidelines on pulse oximetry. The Health Board has a significant amount of work to do on this issue, noting that pulse oximetry is used so widely, by so many different staff, in different clinical situations. However, our inquiries indicate that this issue also extends beyond the Health Board to the manufacturers, who install default alarm levels in their products, and the extent to which they support and facilitate user adjustment of alarm levels. Accordingly there are likely to be issues to be considered beyond BCU Health Board, and we will raise these both at Wales level, and at UK level through the MHRA (Medicines and Healthcare products Regulatory Agency).”

Source location

Kay-Sheard-Response
Page 1 · response
Published 21 December 2015

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.1

  1. 1

    Review pulse oximeter device holdings across the Health Board.

    Stated by Betsi Cadwaladr University LHBStated completedThe respondent said that this action was complete when they made their response on 21 December 2015.

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 pulse oximeter device holdings across the Health Board.

Verbatim wording from the response

“Since receiving the report BCU has done a significant amount of work in reviewing device holdings, checking device settings, and scoping the Action Plan for an inventory of approximately 1200 devices of varying complexity across the Health Board.”

Source location

Kay-Sheard-Response
Page 1 · response
Published 21 December 2015

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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