BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIC

    MDR report key: 1170545 · Received September 11, 2008

    Report

    Report Number
    3023750-2008-00217
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K012766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE COMPLAINT WAS CONFIRMED AND CAUSED BY A RELAY ON THE POWER SUPPLY CIRCUIT BOARD THAT WOULD NO LONGER CHANGE STATES, THEREFORE, WHEN THE DEVICE WAS TRANSFERRED FROM BATTERY TO AUXILIARY POWER, THE DEVICE WOULD NOT ACTIVATE. REPLACEMENT OF THE RELAY RESOLVED THE ISSUE. UPON COMPLETION OF REPAIRS, THE DEVICE PASSED RELEASE TESTING AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE DEVICE TURNS OFF WHEN THE CHARGER IS CONNECTED. NO PT 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