BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 600925 · Received April 5, 2005

    Report

    Report Number
    81440-2005-00013
    Event Type
    Other
    Date Received
    April 5, 2005
    Date of Event
    February 23, 2005
    Report Date
    April 5, 2005
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS RETURNED TO OPERATING ROOM FOR BLEEDING. "TAH-T IN USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART DSQ SYNCARDIA SYSTEMS, INC. TAH-T 56471

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other