BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE HVAD

    MDR report key: 2914460 · Received January 14, 2013

    Report

    Report Number
    2914460
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    January 5, 2013
    Report Date
    January 11, 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

    LOW POWER ALARM. REQUIRED CONTROLLER CHANGE WHICH STOPPED THE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20152 HEARTWARE HVAD LVAD DSQ HEARTWARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1