BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 3222910 · Received July 12, 2013

    Report

    Report Number
    3222910
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    January 3, 2013
    Report Date
    July 8, 2013
    Manufacturer
    HEARTWARE, 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

    CONTROLLER CREATED A LOW BATTERY TONE, SCREEN TURNED OFF; ALSO SYSTEM MONITOR SCREEN TURNED OFF. THE BATTERY MAINTAINED POWER, PUMP DID NOT STOP. CONTROLLER REGISTERED CONNECTED TO 2 BATTERIES WITH AC PLUG BUT ONLY 1 BATTERY PLUGGED IN. CONTROLLER CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323597 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1