BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 2962500 · Received February 14, 2013

    Report

    Report Number
    2962500
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    August 9, 2012
    Report Date
    February 14, 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

    SEVERAL FAULT ALARMS THROUGHOUT STAY. LOW OUTPUT ALARM DL KINKED FILL VOLUME ALARMS.PT WAITED IN HOSPITAL UNTIL TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66141 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1