BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3116601 · Received May 16, 2013

    Report

    Report Number
    3116601
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    June 14, 2012
    Report Date
    May 9, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LAID HIS HEAVY PORTABLE DRIVER (FREEDOM DRIVER) ON HIS LAP AND INADVERTENTLY PINCHED OFF THE PNEUMATIC LINE ACCUATING HIS TAH; RESULTS WERE IMMEDIATE SYNCOPE. PATIENT REGAINED LOC QUICKLY ONCE THE DRIVER FELL OUT OF HIS LAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217301 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1