BEUDAMED
    FDA Adverse Event Death Summary report: N

    GE APEX PRO TELEMETRY MONITOR

    MDR report key: 8209461 · Received December 29, 2018

    Report

    Report Number
    8209461
    Event Type
    Death
    Date Received
    December 29, 2018
    Date of Event
    November 25, 2018
    Report Date
    December 27, 2018
    Manufacturer
    GE MEDICAL SYSTEMS
    Product Code
    MHX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ON TELEMETRY BEING MONITORED THROUGHOUT THE DAY AND AT 18:50, THE NURSE IDENTIFIED THAT THERE WAS NO RHYTHM DISPLAYED ON THE MONITOR. SHE ENTERED THE PT'S ROOM AND FOUND THE PT PULSELESS AND APNEIC. ATTEMPTS TO RESUSCITATE THE PT WERE UNSUCCESSFUL. THE LAST TRANSMISSION FROM THE MONITOR HAD COME AT 17:43 SAYING LF: NO TELEM. IT WAS IDENTIFIED THAT THE BATTERIES HAD RUN OUT, HOWEVER, THE "CHANGE BATTERY" ALARM DID NOT FIRE AT THE CENTRAL MONITORING STATION. SUBSEQUENT TESTING OF THE DEVICE WITH REPLACEMENT BATTERIES FOUND IT TO BE FUNCTIONING APPROPRIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044383 GE APEX PRO TELEMETRY MONITOR TELE PACK MHX GE MEDICAL SYSTEMS 2001989-134

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death