BEUDAMED
    FDA Adverse Event Death Summary report: N

    CIC PRO

    MDR report key: 8744017 · Received June 27, 2019

    Report

    Report Number
    MW5087671
    Event Type
    Death
    Date Received
    June 27, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 25, 2019
    Manufacturer
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S TELEMETRY ALARMS WERE COMPLETELY DISABLED, A LETHAL ARRHYTHMIA OCCURRED; NO ALARM OCCURRED TO ALERT CLINICAL STAFF. THE CAPABILITY TO UTILIZE "ALL ALARMS OFF" WAS DISABLED FOLLOWING EVENT, HOWEVER THE GE PASSCODE TO CHANGE SETTINGS IS THE SAME FOR ALL CUSTOMERS AND IS WIDELY AVAILABLE (I.E., IN MANUAL, ON INTERNET, ETC). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531815 CIC PRO DETECTOR AND ALARM, ARRHYTHMIA DSI GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MP100D

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death