BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1112057 · Received August 5, 2008

    Report

    Report Number
    3023750-2008-00187
    Event Type
    Malfunction
    Date Received
    August 5, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 14, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. FACTORY SERVICE DUPLICATED THE COMPLAINT. WHEN THE DEVICE IS SHAKEN, THE DISPLAY WILL INTERMITTENTLY GO OFF AND ON. THE CAUSE OF THE FAILURE IS DUE TO OPEN FOIL RUNS INTERNAL TO THE DISPLAY CABLE (RESULT CODE 423) CAUSING AN INTERMITTENT OPEN (RESULT CODE 122). WHEN THE DEVICE IS MOVED OR SHAKEN, THESE FOIL RUNS WILL OPEN AND CAUSE THE DISPLAY TO GO BLANK. THE CAUSE OF THE FAILURE IS INCONCLUSIVE. REPLACEMENT OF THE CABLE RESOLVED THE ISSUE. ONCE THE CABLE WAS REPLACED, THE DEVICE PERFORMED TO SPECIFICATIONS. UPON COMPLETION OF THE REPAIRS, THE DEVICE PASSED ALL RELEASE TESTING AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER INDICATES THE DISPLAY INTERMITTENTLY GOES BLANK. 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