BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO. LTD

    MDR report key: 1574155 · Received December 16, 2009

    Report

    Report Number
    2243801-2009-00009
    Event Type
    Malfunction
    Date Received
    December 16, 2009
    Date of Event
    September 28, 2009
    Report Date
    December 10, 2009
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    DYB
    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 NOT RETURNED TO THE MANUFACTURER TO BE EVALUATED. THE HOUSE RETAIN SAMPLE FOR THE REPORTED LOT WAS CONTINUALLY 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. WITHOUT THE ACTUAL SAMPLE A THOROUGH EVALUATION COULD NOT BE PERFORMED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. THERE ARE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER.

    Description of Event or Problem · 1

    A PACING FAILURE OCCURRED WHILE IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYB B. BRAUN MEDICAL, INC. NA 61031978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other