BEUDAMED
    FDA Adverse Event Death Summary report: N

    78720A ARRHYTHMIA MONITORING SYSTEM

    MDR report key: 37633 · Received September 6, 1996

    Report

    Report Number
    1218950-1996-00003
    Event Type
    Death
    Date Received
    September 6, 1996
    Date of Event
    August 8, 1996
    Report Date
    September 5, 1996
    Manufacturer
    HEWLETT-PACKARD CO
    Product Code
    DRT
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE ARRHYTHMIA MONITORING SYSTEM DID NOT ALARM PROPERLY. THEY FELT THERE SHOULD HAVE BEEN A THREE STAR ALARM BEFORE THE PT WENT INTO ASYSTOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 78720A ARRHYTHMIA MONITORING SYSTEM ARRHYTHMIA MONITORING SYSTEM DRT HEWLETT-PACKARD CO 78720A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death