BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODTECH

    MDR report key: 1250775 · Received December 1, 2008

    Report

    Report Number
    2243801-2008-00011
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    September 17, 2008
    Report Date
    November 21, 2008
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED BALLOON CATHETER SAMPLE WAS RETURNED FOR EVALUATION. THE SAMPLE PASSED ALL VISUAL EVALUATION. A CONTINUITY TEST WAS PERFORMED PER SPECIFICATION AND THE SAMPLE WAS NOTED TO PASS ALL TESTING ON BOTH ELECTRODES. THE REPORTED INCIDENT COULD NOT BE DUPLICATED WITH THE ACTUAL RETURNED SAMPLE. NO SPECIFIC CONCLUSIONS CAN BE DRAWN.

    Description of Event or Problem · 1

    REPORTS A PACING FAILURE. PACING INSERTED AND CONNECTED TO UNIT. PACING ATTEMPTED BUT UNABLE TO BE PERFORMED. RECONNECTED, BUT PROBLEM PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODTECH BIPOLAR PACING CATHETER DYG B. BRAUN MEDICAL INC. NA 60965010

    Patients

    Seq Age Sex Outcome Treatment
    1