BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO. LTD

    MDR report key: 1478547 · Received June 26, 2009

    Report

    Report Number
    2243801-2009-00005
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Date of Event
    April 29, 2009
    Report Date
    June 18, 2009
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE REPORTED INCIDENT WAS RETURNED TO THE MANUFACTURER TO BE EVALUATED. CONTINUITY TESTING WAS PERFORMED PER SPECIFICATION ON THE RETURNED SAMPLE. THE TESTING WAS CONDUCTED WITH VIGOROUS MANIPULATION TO THE CATHETER BODY, MANIFOLD AND LEADS (EXCESSIVE BENDING, SQUEEZING, ETC.) AND NO ABNORMALITY WAS FOUND. THE PROXIMAL LINE AND DISTAL LINE HAD PERFECT CONTINUITY AND THERE WAS NO SHORT CIRCUIT IN THE CATHETER ELECTRICAL SYSTEM. THE HOUSE RETAIN SAMPLE FOR THE REPORTED LOT WAS ALSO 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

    PACING FAILURE WHILE 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 61009462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other