BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1032394 · Received April 16, 2008

    Report

    Report Number
    3023750-2008-00106
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    February 26, 2008
    Report Date
    March 19, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED, THE COMPLAINT WAS CONFIRMED AND CAUSED BY THE PREAMP CABLE BECOMING UNSEATED FROM ITS CONNECTOR CAUSING AN OPEN CIRCUIT. CAUSE OF THE CABLE BECOMING UNSEATED IS INCONCLUSIVE. REINSERTION OF THE CABLE RESOLVED THE FAILURE. AFTER REPAIR, THE DEVICE PERFORMED TO SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATES THAT THERE IS NO ECG SIGNAL ON THE DISPLAY DURING A ROUTINE CHECK. NO PATIENT 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