BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTSTART SEMIAUTOMATIC DEFIBRILLATOR

    MDR report key: 20172 · Received March 8, 1995

    Report

    Report Number
    MW1005361
    Event Type
    Death
    Date Received
    March 8, 1995
    Date of Event
    January 24, 1995
    Report Date
    March 2, 1995
    Manufacturer
    LAERDAL MEDICAL CORP.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AED APPEARS TO HAVE FAILED IN ASSESSING COARSE V-FIB DURING FIRST TWO "ASSESS" MODES BUT INSTEAD GAVE MESSAGE "CHECK BREATHING AND PULSE". THIRD ASSESSMENT PROMPTED BY FIRE FIGHTERS AT 2 MIN 12 SEC DID RESULT IN "CHARGE" AND SUBSEQUENT DEFIBRILLATION BY FIRE FIGHTERS. PT THEN WENT INTO ASYSTOLE FOLLOWED BY PEA. (*)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART SEMIAUTOMATIC DEFIBRILLATOR SEMIAUTOMATIC DEFIBRILLATOR MKJ LAERDAL MEDICAL CORP. 1000S

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death