BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED

    MDR report key: 1024219 · Received March 27, 2008

    Report

    Report Number
    3023750-2008-00090
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 28, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K021168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE COMPLAINT WAS CONFIRMED. INVESTIGATION ISOLATED THE CAUSE OF THE MALFUNCTION TO AN INTERNAL FAULT IN AN OSCILLATOR ON THE "MAIN" PRINTED CIRCUIT BOARD. THE INTERNAL FAULT SHORTED A POWER SOURCE TO GROUND, RENDERING THE ENTIRE BOARD INOPERABLE. THE BOARD WITH THE FAULTY OSCILLATOR WAS REPLACED TO RESTORE DEVICE FUNCTION. AFTER REPAIR, THE DEVICE PERFORMED TO SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WITH A NEW BATTERY, THE DEVICE DOES NOT TURN ON AND THE STATUS INDICATOR FLASHES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ MKJ WELCH ALLYN PROTOCOL, INC. AED10

    Patients

    Seq Age Sex Outcome Treatment
    1