PFD report

Mr Thomas Smith Collings · Prevention of Future Deaths report

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Issued 15 Apr 2019•Sunderland

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
2

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
9

Described in 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.

Report evidence summary

Concerns raised2

  1. Failure of the alert algorithm to provide earlier differentiation between detached-lead artefacts and life-threatening ventricular defibrillation
    Part of recurring concern: Unreliable clinical safety-alert systems
  2. Lack of timely refresher training on maintenance of monitor lead attachments
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

    Implement escalating ECG technical alarms for “Arrhythmia Paused” and “Leads Off” states, including configurable escalation to a high-priority alarm.

    Stated by GE HealthcareStated completedThe respondent said that this action was complete when they made their response on 15 April 2019.
  2. Action

    Implement improved ventricular fibrillation detection using spectral analysis, faster alarm processing and data from all available ECG leads.

    Stated by GE HealthcareStated completedThe respondent said that this action was complete when they made their response on 15 April 2019.
  3. Action

    Deliver comprehensive staff training for the new monitoring system, including alarm classifications, lead attachment maintenance and train-the-trainer provision.

    Stated by South Tyneside and Sunderland NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 15 April 2019.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.2

  1. Position

    The automated ECG arrhythmia detection algorithm operated within specifications and industry standards; signal conditions and rare rhythm prevented the alarm.

    Stated by GE HealthcareDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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 the alert algorithm to provide earlier differentiation between detached-lead artefacts and life-threatening ventricular defibrillation

Wider context from the report

“I should be glad to be told about any additional learning arising from the evidence heard at the Inquest especially with regard to the evidence of your engineer ████████ and In particular, are there any improvements to the algorithm for earlier alerts, especially those that may differentiate sooner between any artefact, such as a detached lead, and a life-threatening event, such as a ventricular defibrillation, recognisable by the human eye? ”

Is this part of a recurring concern?

Yes — Unreliable clinical safety-alert systems.

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

Lack of timely refresher training on maintenance of monitor lead attachments

Wider context from the report

“Although the letter of 8th February 2019 from the Trust’s Solicitors set out the likely steps to be taken, I should be glad to be told of any additional learning arising from the evidence heard at the Inquest, especially with regard to the evidence of ████████ of GE Healthcare and ████████. In particular, what are the timescales for implementation and refresher training in respect of the importance of maintenance of the lead attachments to ensure optimal performance of the monitors? ”

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

Implement escalating ECG technical alarms for “Arrhythmia Paused” and “Leads Off” states, including configurable escalation to a high-priority alarm.

Verbatim wording from the response

“GE Healthcare has implemented ECG Technical Alarm notification improvements when the automated ECG algorithm detects noise and/or artifact. The current GE Healthcare CARESCAPE B850/B650/B450 Patient Monitoring platform provides escalating ECG Technical Alarms for “Arrhythmia Paused” and “Leads Off” states. These improvements allow clinicians to configure “Arrhythmia Paused” and “Leads Off” Technical Alarms to escalate to a high “red” alarm rather than a warning or advisory alarm. This functionality was introduced in the CARESCAPE product line in 2009. In Mr. Collings’ case, based on the ECG tracings and log file information, the “Arrhythmia Paused” Technical Alarm would have escalated to a high “red” alarm at approximately 01:21:53, alerting caregivers to the loss of ECG monitoring and arrhythmia alarm detection capability.”

Source location

2019-0260-Response-by-GE-Healthcare
Page 2 · response
Published 15 April 2019

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 improved ventricular fibrillation detection using spectral analysis, faster alarm processing and data from all available ECG leads.

Verbatim wording from the response

“GE Healthcare has also implemented improvements in the signal processing specific to the detection of Ventricular Fibrillation. The current GE Healthcare CARESCAPE B850/B650/B450 Patient Monitoring platform uses a spectral analysis technique within the EK-Pro algorithm that was not possible in the previous generation platforms due to the computational demands. The primary performance benefits of the newer technology include a shorter average time to alarm and the capability to utilize the data in all available leads (e.g., I, II, III, V) when the analysis is updated each second. Testing of the algorithm improvements via the requirements of AAMI/ANSI EC-57 confirm the reduced alarm delay relative to the older technology.”

Source location

2019-0260-Response-by-GE-Healthcare
Page 2 · response
Published 15 April 2019

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

Deliver comprehensive staff training for the new monitoring system, including alarm classifications, lead attachment maintenance and train-the-trainer provision.

Verbatim wording from the response

“The Directorate developed a business case for a new monitoring system for CCU from an alternative supplier. I am pleased to inform you that the Trust approved this business case, the equipment has been purchased and the enabling work for the installation has now commenced. Staff training on the new monitoring equipment has been procured as part of the process and there will be a full and comprehensive training package delivered as part of this changeover. Our estates department is currently installing additional network cabling throughout the unit, so we do not yet have a completion date for the installation of the monitoring system, but we estimate that this will be in the Autumn.”

Source location

2019-0260-Response-by-South-Tyneside-and-Sunderland-NHS-Trust
Page 1 · response
Published 15 April 2019

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 automated ECG arrhythmia detection algorithm operated within specifications and industry standards; signal conditions and rare rhythm prevented the alarm.

Verbatim wording from the response

“In the case involving Mr. Thomas Collings, following an investigation, GE Healthcare concluded that the automated ECG arrhythmia detection algorithm (EK-Pro), being used to monitor Mr Collings performed within specifications and ECG monitoring industry standards based on the available information and Full Disclosure data captured. The signal acquisition conditions combined with the extremely rare “Torsades de Pointes” ECG rhythm Mr. Collings presented with on the morning of August 2, 2018 prevented the algorithm from asserting a Ventricular Fibrillation (“VF”) or Ventricular Tachycardia (“VT”) arrhythmia alarm. Unfortunately, ECG tracings for leads I, II and V were not available for review to further the assessment.”

Source location

2019-0260-Response-by-GE-Healthcare
Page 1 · response
Published 15 April 2019

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

A definitive commencement timescale for staff training cannot be provided until enabling works for the new monitoring system are completed.

Verbatim wording from the response

“Unfortunately, until we have confirmation of when these enabling works will be completed, I am unable to provide you with the definitive timescales for the commencement of this training, as it needs to be organised around the installation date. However, I have provided a copy of the training programme (please see attached).”

Source location

2019-0260-Response-by-South-Tyneside-and-Sunderland-NHS-Trust
Page 1 · response
Published 15 April 2019

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.6

  1. 1

    Require the complaint-handling team to request data from all available monitoring leads when initiating relevant investigations.

    Stated by GE HealthcareStated completedThe respondent said that this action was complete when they made their response on 15 April 2019.
  2. 2

    Raise staff awareness of cardiac monitor artefact alarms and require immediate alarm review, patient attendance and visual checks.

    Stated by South Tyneside and Sunderland NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 15 April 2019.
  3. 3

    Clarify with monitoring manufacturers the device-log data required for complete technical inspection and testing.

    Stated by South Tyneside and Sunderland NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 15 April 2019.
  4. 4

    Augment observation of the CCU central monitor console through increased nursing staffing levels.

    Stated by South Tyneside and Sunderland NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 15 April 2019.
  5. 5

    Oversee progress of the stated safety actions and report updates to the Trust’s Clinical Governance Steering Group.

    Stated by South Tyneside and Sunderland NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 15 April 2019.
  6. 6

    Install and implement the approved alternative CCU monitoring system, including enabling network cabling works.

    Stated by South Tyneside and Sunderland NHS Foundation TrustStated in progressThe respondent said that this action was in progress when they made their response on 15 April 2019.

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

  1. 1

    The existing TRAM and Solar 8000M monitoring system remains effective when used in accordance with its operator’s manual.

    Stated by GE HealthcareExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

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 the complaint-handling team to request data from all available monitoring leads when initiating relevant investigations.

Verbatim wording from the response

“Following the incident involving Mr Collings where it became apparent that data for all leads had not been captured by the Trust at the time, GE Healthcare has also re-iterated to its complaint handling team to request data from all available monitoring leads when initiating an investigation, in an effort to ensure that as much data as possible is provided when reviewing a complaint or report requiring investigation.”

Source location

2019-0260-Response-by-GE-Healthcare
Page 2 · response
Published 15 April 2019

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

Raise staff awareness of cardiac monitor artefact alarms and require immediate alarm review, patient attendance and visual checks.

Verbatim wording from the response

“As you are aware, the Trust takes all patient deaths extremely seriously and we undertake mortality reviews to establish if lessons can be learned and services improved. In this case, we also completed a comprehensive investigation/Root Cause Analysis with regard to the functioning of Mr Collings’ cardiac monitor when he suffered a fatal heart arrhythmia in the coronary care unit (CCU) on 2nd August 2018. As part of the learning from this internal investigation, the clinical team identified the need for increasing staff awareness in respect of cardiac monitor alarms sounding for artefact purposes and this was immediately addressed at the time by the department manager.”

Source location

2019-0260-Response-by-South-Tyneside-and-Sunderland-NHS-Trust
Page 1 · response
Published 15 April 2019

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

Clarify with monitoring manufacturers the device-log data required for complete technical inspection and testing.

Verbatim wording from the response

“Collings’ cardiac monitor was suspected by the clinical team, our electronics department isolated the monitor for inspection and testing and retrieved the electrocardiogram (ECG) waveform data from the device log file. However, in this instance, the data was only printed off from one of the four monitoring leads, which was insufficient for a full review by the manufacturer. In future, our Hospital Biomedical Engineering Manager will clarify with manufacturers exactly what data needs to be obtained from the device log file to allow a full and thorough inspection.”

Source location

2019-0260-Response-by-South-Tyneside-and-Sunderland-NHS-Trust
Page 2 · response
Published 15 April 2019

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

Augment observation of the CCU central monitor console through increased nursing staffing levels.

Verbatim wording from the response

“The incident has been discussed at the Directorate Clinical Governance meeting and nursing team meetings, with an emphasis on the requirement for staff to review alarms immediately and attend to the patient in order to undertake a visual check. Additionally, there is now augmented observation of the central monitor console on CCU by nursing staff, aided by an increase in the staffing levels.”

Source location

2019-0260-Response-by-South-Tyneside-and-Sunderland-NHS-Trust
Page 1 · response
Published 15 April 2019

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

Oversee progress of the stated safety actions and report updates to the Trust’s Clinical Governance Steering Group.

Verbatim wording from the response

“As you will note, the Trust is addressing the shortfalls highlighted during our investigation and the Inquest, in order to prevent future deaths in similar circumstances. Progress of the actions detailed in this letter will be overseen by ████████, our Executive Director of Nursing, Midwifery and Allied Health Professionals, who will also keep me briefed and report to the Trust’s Clinical Governance Steering Group.”

Source location

2019-0260-Response-by-South-Tyneside-and-Sunderland-NHS-Trust
Page 2 · response
Published 15 April 2019

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

Install and implement the approved alternative CCU monitoring system, including enabling network cabling works.

Verbatim wording from the response

“The Directorate developed a business case for a new monitoring system for CCU from an alternative supplier. I am pleased to inform you that the Trust approved this business case, the equipment has been purchased and the enabling work for the installation has now commenced. Staff training on the new monitoring equipment has been procured as part of the process and there will be a full and comprehensive training package delivered as part of this changeover. Our estates department is currently installing additional network cabling throughout the unit, so we do not yet have a completion date for the installation of the monitoring system, but we estimate that this will be in the Autumn.”

Source location

2019-0260-Response-by-South-Tyneside-and-Sunderland-NHS-Trust
Page 1 · response
Published 15 April 2019

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 existing TRAM and Solar 8000M monitoring system remains effective when used in accordance with its operator’s manual.

Verbatim wording from the response

“The TRAM and Solar 8000M patient monitoring system used in the Sunderland Coronary Care Unit was a state-of-the-art technology in 2004 when it was manufactured. If used in accordance with the operator’s manual, the TRAM and Solar 8000M patient monitoring system is still an effective physiological patient monitoring device today.”

Source location

2019-0260-Response-by-GE-Healthcare
Page 1 · response
Published 15 April 2019

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

Official responses located
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Data last updated 7 September 2026