BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO. LTD

    MDR report key: 1651780 · Received March 29, 2010

    Report

    Report Number
    2243801-2010-00004
    Event Type
    Malfunction
    Date Received
    March 29, 2010
    Date of Event
    January 1, 2010
    Report Date
    March 16, 2010
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    DYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE SAMPLE WAS CONTINUITY TESTED PER SPECIFICATION AND WAS NOTED TO PASS ALL TESTING ON BOTH ELECTRODES. THERE WAS NO LOSS IN CONTINUITY THAT COULD RESULT IN PACING FAILURE. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    REPORTS CAN NOT DO PACING WHEN DEVICE IS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYG B. BRAUN MEDICAL INC. NA 61038268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other