BEUDAMED
    FDA Adverse Event Death Summary report: N

    1600 SEMI AUTOMATIC DEFIBRILLATOR

    MDR report key: 57032 · Received December 11, 1996

    Report

    Report Number
    1220908-1996-00123
    Event Type
    Death
    Date Received
    December 11, 1996
    Date of Event
    November 9, 1996
    Report Date
    December 11, 1996
    Manufacturer
    ZOLL MEDICAL CORPORATION
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT ALLEGED THAT MEDICS DEFIBRILLATED A 74 YR OLD MALE PT FOUR TIMES. AFTER THE FOURTH DEFIBRILLATION ATTEMPT. THE UNIT'S MONITOR SCREEN DISPLAYED A DOTTED LINE AN ECG TRACE AND AN "CHECK ELECTRODES" MESSAGE. THE MEDICS DISCONNECTED AND RECONNECTED THE MULTI-FUNCTION CABLE AND ELECTRODES, BUT THE ALLEGED MALFUNCTION CONTINUED. THE MEDICS OBTAINED ANOTHER UNIT AND CONTINUED TO MONITOR TO PT. THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1600 SEMI AUTOMATIC DEFIBRILLATOR DEFIBRILLATOR MKJ ZOLL MEDICAL CORPORATION 1600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 * Death