BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1013985 · Received March 13, 2008

    Report

    Report Number
    3023750-2008-00080
    Event Type
    Malfunction
    Date Received
    March 13, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. FACTORY SERVICE CONFIRMED THE REPORTED FAILURE OF THE EXTERNAL PACER FUNCTION UPON POWERING UP THE UNIT. THEY ISOLATED THE ERROR TO INTERMITTENT CONNECTIONS ON CONNECTOR J2 ON THE PREAMP BOARD. THE INTERMITTENT CONNECTIONS INTERFERED WITH THE DEVICE'S ABILITY TO ANALYZE CAPTURE BEATS, WHICH IS NECESSARY TO DELIVER PACER PULSES. THEY REPLACED THE CABLE AND CONNECTOR PER SERVICE PROCEDURE TO RESOLVE THE ISSUE. AFTER CABLE REPLACEMENT, THE DEVICE PASSED TESTING AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE UNIT HAD INTERMITTENT PROBLEMS WITH THE EXTERNAL PACING FUNCTION. THE UNIT COULD NOT CAPTURE THE PATIENT'S ECG WAVEFORM. THEY CHANGED LEAD ELECTRODES AND PADS WITHOUT SUCCESS. THE CUSTOMER USED ANOTHER DEVICE TO PROVIDE THE EXTERNAL PACING THERAPY TO THE PATIENT. THERE WAS NO PATIENT HARM ATTRIBUTED TO THIS FAILURE.

    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 85 YR