BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED

    MDR report key: 1030549 · Received April 15, 2008

    Report

    Report Number
    3023750-2008-00103
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    January 8, 2008
    Report Date
    March 24, 2008
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K021168
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS EVALUATED. THE DEVICE WAS RETURNED FOR ROUTINE MAINTENANCE (SOFTWARE UPDATE). TESTING FOUND THE DEVICE WAS DELIVERING LESS THAN THE SELECTED ENERGY OUTPUT. INVESTIGATION FOUND THAT THE LOW ENERGY DELIVERY WAS DUE TO A CRACKED SOLDER JOINT ON ONE PIN OF A TRANSFORMER ON THE DEFIB CIRCUIT BOARD. THE CIRCUIT BOARD WAS REPLACED TO CORRECT THE PROBLEM. AFTER REPAIR, THE DEVICE PERFORMED TO SPECS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE RETURNED FOR A SOFTWARE UPGRADE WHERE AFTER DEVICE MODIFICATIONS, FACTORY SERVICE DISCOVERED THAT THE DEVICE WAS SHOCKING AT 25% OF SETTING. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ WELCH ALLYN PROTOCOL, INC. AED 10

    Patients

    Seq Age Sex Outcome Treatment
    1