Recipient

GE Healthcare

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First report 15 Apr 2019•Latest report 15 Apr 2019

Recipient record

Reports, concerns and published responses

Private and voluntary organisations · Company. This page brings together reports naming this recipient and response statements clearly connected to concerns raised in those reports.

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
1

Across all linked responses

Stated actions
3

Described in responses

Reports over time

Reports over time

Reports naming this recipient by issue year.

Evidence profile

Report topics

Share of this recipient’s reports compared with all other recipients.

100%published responses found
3stated actions described

Topic comparisons are not available in the current evidence snapshot.

Concerns and recipient responses

Statements from GE Healthcare linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. Sunderland

    AI-generated summary

    Mr Thomas Smith Collings · 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

    Mr Thomas Smith Collings suffered unexpected ventricular fibrillation at Sunderland Royal Hospital on 2 August 2018 and was found several minutes later without effective cardiac output. The report identified failures to detect the ventricular fibrillation, including ECG monitoring not detecting the rhythm, the crisis alarm not sounding, artefact obscuring the trace, and delays in attendance. The substantive concern was whether improvements to monitoring algorithms could enable earlier alerts and better distinguish artefact from a life-threatening event.

    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. The report was sent to GE Healthcare; that does 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? ”
    Open source report

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to GE Healthcare; that does 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? ”
    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 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
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Published response patterns

Compared with other recipients in reports included in PFD Monitor

Describes published response evidence, not performance.

Published responses found

100%
100%All other recipients 58%
0%100%

How actions were described at the time

This respondent
100%
All other recipients
47%25%27%<1%<1%
  • Completed
  • In progress
  • Planned
  • Unclear
  • Partially completed

Statuses reflect what recipients said at the time. PFD Monitor does not verify whether actions happened.

Types of action described in responses

Percentages use all actions described by each group. An action may have more than one type, so percentages do not total 100%.

Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026