BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2959860 · Received February 13, 2013

    Report

    Report Number
    2959860
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    November 4, 2012
    Report Date
    February 13, 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

    WHILE CHANGING BATTERIES THE RED HEART ALARM WENT OFF AND THE PUMP STOPPED FOR LESS THAN 2 MINUTES. A 911 TRANSPORT TO KMC WHERE IT SHOWED A LOW VOLTAGE AND LOW FLOW ALARM ADVISORY. ENGINEER SAID PUMP STOPPAGE FROM FAULTY BATTERY CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62933 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1