BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1082701 · Received July 21, 2008

    Report

    Report Number
    3023750-2008-00177
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE IS A WELCH ALLYN OWNED LOANER AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) DEVICE. THE FACTORY SERVICE TECHNICIAN ISOLATED THE PROBLEM TO A LEAD ON A CONNECTOR WHICH HAD PUNCTURED THE NOMEX BARRIER BETWEEN THE PROTECTION BOARD AND THE EXTERNAL CASE. THIS ENABLED LEAKAGE CURRENT IN EXCESS OF THE SPECIFICATION TO ESCAPE WHEN HIGH VOLTAGE WAS APPLIED DURING HIPOT TESTING. WE TRIMMED THE LEAD AND REPLACED THE NOMEX BARRIER TO RESTORE NORMAL OPERATION. THE DEVICE PASSED ALL TESTING AND RETURNED TO THE REFURBISHMENT POOL OF DEVICES.

    Description of Event or Problem · 1

    FACTORY SERVICE FOUND THAT THE DEVICE FAILED PADDLE HIPOT TEST DURING FINAL TESTING. THIS FAILURE OCCURRED ON THE SERVICE BENCH INSIDE THE FACTOR. WE WOULD NOT NORMALLY EXPECT TO SEE THIS FAILURE OCCUR IN THE FIELD. NONETHELESS, WE CONSIDER THIS TO BE A REPORTABLE SECONDARY FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIC MKJ WELCH ALLYN PROTOCOL, INC. PIC 40

    Patients

    Seq Age Sex Outcome Treatment
    1