BEUDAMED
    FDA Adverse Event Other Summary report: N

    AED

    MDR report key: 843335 · Received April 30, 2007

    Report

    Report Number
    3023750-2007-00117
    Event Type
    Other
    Date Received
    April 30, 2007
    Date of Event
    April 4, 2007
    Report Date
    April 5, 2007
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K002232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S EVAL SUMMARY: THE DEVICE IS AN AUTOMATIC EXTERNAL DEFIBRILLATOR AND THE ACTUAL DEVICE INVOLVED WAS RETURNED FOR EVAL. ANALYSIS OF THE DEVICE CONFIRMED THE ERROR CODE AND THE CAUSE OF THE FAILURE WAS DUE TO AN OPEN FOIL IN THE DEFIB BOARD CABLE. THE OPEN CABLE WAS DUE TO MISROUTING FROM THE PREVIOUS COMPLETED REPAIR SERVICE. AFTER REPLACEMENT OF THE CABLE, THE DEVICE PERFORMS TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER CHECKED HIS AED20 AND IT DISPLAYED A "DEFIB COMM" ERROR ON POWER UP. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AED MKJ MKJ WELCH ALLYN PROTOCOL, INC. AED 20

    Patients

    Seq Age Sex Outcome Treatment
    1 YR