BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE DEFENSE PLUS

    MDR report key: 103650 · Received July 2, 1997

    Report

    Report Number
    1381607-1997-00009
    Event Type
    Malfunction
    Date Received
    July 2, 1997
    Date of Event
    May 19, 1997
    Report Date
    May 19, 1997
    Manufacturer
    MATRX MEDICAL, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TESTING, SCREEN SHOWS 10 JLS ON POWER UP; CHARGE ATTEMPT GIVES ERROR CODE 010. PROBLEM REPEATS. HAPPENED A FEW WEEKS PRIOR TO REPORT, BUT CLEARED SUCCESSFULLY. UNABLE TO CLEAR AND USE NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE DEFENSE PLUS DEFIBRILLATOR/MONITOR/PACER LDD MATRX MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *