BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL DEFIBRILLATOR PADS

    MDR report key: 1840177 · Received September 14, 2010

    Report

    Report Number
    MW5017452
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    Manufacturer
    DIXIE MEDICAL INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN OPENING THE DEFIBRILLATOR PADS FOR THE ZOLL DEFIBRILLATOR - THE JUMPWIRE IS ATTACHED AND NEAR FOIL ON THE PACKAGING; AS A RESULT, THE DEFIB STAYS IN "TEST MODE" AND THE PT DOES NOT RECEIVE THE JOULES THE DEFIB IS SET FOR. THE JUMP WIRE NEEDS TO BE REMOVED FROM THE PACKAGING AND ALL FOIL REMOVED FOR THE PADS TO WORK CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZOLL DEFIBRILLATOR PADS DEFIBRILLATOR PADS MKJ DIXIE MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other