BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1082724 · Received July 22, 2008

    Report

    Report Number
    3023750-2008-00178
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 7, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR. THE CUSTOMER RETURNED THE ACTUAL DEVICE INVOLVED FOR EVAL. THE COMPLAINT WAS CONFIRMED AND CAUSED BY A CABLE (RESULT CODE 423) BECOMING DISCONNECTED FROM ITS ASSOCIATED CONNECTOR (RESULT CODE 435). ONCE THE CABLE WAS RESEATED INTO THE CONNECTOR, THE DEVICE OPERATED TO SPECIFICATIONS. FACTORY SERVICE UPGRADED, TESTED, AND RETURNED THE DEVICE TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THE DEVICE WILL NOT DEFIBRILLATE. THIS WAS DISCOVERED DURING ROUTINE TESTING. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC 50

    Patients

    Seq Age Sex Outcome Treatment
    1