BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2962451 · Received February 14, 2013

    Report

    Report Number
    2962451
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    October 15, 2012
    Report Date
    February 14, 2013
    Manufacturer
    THORATEC CORPORATION
    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

    PATIENT WAS EXPERIENCING RED HEART ALARMS, THE CONTROLLER WAS SENT BACK TO THE MANUFACTURER AND UPON REVIEW, THERE WERE NO FINDINGS THAT THIS HAD OCCURRED. HOWEVER, UNUSUAL POWER CABLE DISCONNECT EVENTS NOTED UPON REVIEW OF THE CONTROLLER LOG FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64747 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1