BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AED

    MDR report key: 1082721 · Received July 22, 2008

    Report

    Report Number
    3023750-2008-00172
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 10, 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

    MANUFACTURER'S EVALUATION SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR (AED) AND THE ACTUAL DEVICE INVOLVED WAS RETURNED BY THE USER. THE DEVICE RETURNED FOR REPAIR WHEN THE SERVICE TECHNICIAN IDENTIFIED THAT NO AUDIO VOICE PROMPTS WERE BEING GENERATED FROM THE SPEAKER. THE CAUSE OF THE LOSS IN AUDIO IS DUE TO FAILURE OF THE SPEAKER. REPLACEMENT OF THE SPEAKER RESOLVED THE ISSUE. UPON COMPLETION OF REPAIRS, THE DEVICE PASSED RELEASE TESTING AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE DEVICE RETURNED FOR REPAIR WHEN THE SERVICE TECHNICIAN IDENTIFIED THAT NO AUDIO WAS BEING GENERATED FROM THE SPEAKER. 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