BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1031683 · Received April 18, 2008

    Report

    Report Number
    3023750-2008-00108
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 20, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE COMPLAINT WAS CONFIRMED AND CAUSED A WEAK CONNECTION BETWEEN A CABLE (RESULT CODE 423) AND ITS CONNECTOR (RESULT CODE 435) ON THE PREAMP CIRCUIT BOARD. THE CONNECTOR WAS REMOVED AND THE CABLE WAS SOLDERED DIRECTLY TO THE CIRCUIT BOARD PER A RELEASED ENGINEERING CHANGE ORDER TO RESOLVE THE ISSUE. A SECONDARY FINDING IDENTIFIED DURING THE INVESTIGATION IS THAT THE DEVICE WOULD DELIVER 25% OF THE SELECTED ENERGY LEVEL. THIS CONDITION WAS CAUSED BY INSUFFICIENT SOLDER ON A SOLDER JOINT (RESULT CODE 511) GENERATING AN OPEN CIRCUIT (RESULT CODE 122) CAUSING THE LOSS OF HALF THE REQUIRE SIGNAL. RESOLDERING THE CONNECTION RESOLVED THE ISSUE. UPON COMPLETION OF REPAIRS, THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE UNIT HAD AN ECG COMM ERROR WITH NO CABLE ATTACHED. NO PT INVOLVEMENT. FACTORY SERVICE IDENTIFIED THAT THE DEVICE WOULD ONLY DELIVER 25% OF THE SELECTED ENERGY.

    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