BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3135686 · Received May 29, 2013

    Report

    Report Number
    3135686
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 29, 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

    HIGH FAULT ALARM DURING BATTERY SWAP. ABLE TO SWITCH OVER TO BACK UP FREEDOM DRIVER WITHOUT DIFFICULTY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233846 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1