BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDICAL RESEARCH LABORATORIES, INC. (MRL)

    MDR report key: 333278 · Received May 15, 2001

    Report

    Report Number
    333278
    Event Type
    Death
    Date Received
    May 15, 2001
    Date of Event
    May 4, 2001
    Report Date
    May 10, 2001
    Manufacturer
    MEDICAL RESEARCH LABORATORIES, INC.
    Product Code
    MKJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT FOUND IN LOCKED CAR WHEN FIRST REACHED BY PARAMEDIC CREW AND FOUND TO BE IN VENTRICULAR FIBRILLATION. THE MRL 360SLX ECG MON/DEFIB WAS SET FOR 360 JOULES AND WAS DISCHARGED X2 SUCCESSFULLY BUT WITHOUT CONVERTING THE ARRHYTHMIA. WHEN THE 3RD CONSECUTIVE SHOCK WAS ATTEMPTED THE BATTERY GAVE OUT AND THE "SPARE" BATTERY WAS ALSO DEPLETED. THE PT WAS TRANSPORTED TO THE NEAREST APPROVED COMPREHENSIVE ER FACILITY UNDER CPR AND 100% OXYGEN. SHORTLY AFTER THE FAILED 3RD SHOCK, THE PT SELF-CONVERTED TO ASYSTOLE AND REMAINED UNTIL DECLARED DEAD ON ARRIVAL.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 11/7/03: H6. A BROKEN LOW-VOLTAGE MALE PIN FROM THE THERAPY CABLE WAS OBSERVED TO BE STUCK INSIDE THE FEMALE PIN OF THE DEVICE THERAPY CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22853 MEDICAL RESEARCH LABORATORIES, INC. (MRL) MRL MODEL SXL360 MKJ MEDICAL RESEARCH LABORATORIES, INC. MRL MODEL SXL360 *

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death