BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3090614 · Received May 2, 2013

    Report

    Report Number
    3090614
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 30, 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

    PT HAD YELLOW ALARMS WHILE ON THE FDS. THE FDA WAS CHANGED OUT. NO FURTHER ISSUES AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192347 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1