BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOODMAN CO. LTD

    MDR report key: 1743304 · Received June 24, 2010

    Report

    Report Number
    2243801-2010-00009
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    April 19, 2010
    Report Date
    June 21, 2010
    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 RETURNED TO THE MANUFACTURER TO BE EVALUATED. CONTINUITY TESTING WAS PERFORMED PER SPECIFICATION ON THE RETURNED CATHETER 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. 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 THE DEVICE GOT IMPOSSIBLE TO DO PACING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODMAN CO. LTD PACING CATHETER DYB B. BRAUN MEDICAL INC. NA 61043886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other