BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED

    MDR report key: 1031689 · Received April 18, 2008

    Report

    Report Number
    3023750-2008-00109
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 11, 2008
    Report Date
    April 11, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) AND THE ACTUAL DEVICE INVOLVED WAS RETURNED BY THE USER. 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 SURFACE MOUNT TECHNOLOGY TRANSFORMER ON THE DEFIBRILLATOR PRINTED CIRCUIT BOARD. ADDITIONALLY, THE TRANSFORMER HOUSING WAS CRACKED. THE BOARD WAS REPLACED TO CORRECT THE PROBLEM. AFTER REPAIR AND UPDATES, THE DEVICE PERFORMED TO SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED FOR SOFTWARE UPGRADE WHEN TESTING FOUND THAT THE DEVICE DELIVERED 58 JOULES OF ENERGY INSTEAD OF THE EXPECTED 200 JOULES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1