BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3183127 · Received June 21, 2013

    Report

    Report Number
    3183127
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    June 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

    PT HAD RED HEART ALARMS. CHANGED FROM BATTERIES TO PM, ALARMS CONTINUED. PT CHANGED CONTROLLERS, ALARMS STOPPED. FOLLOWING MORNING PT CAME TO CLINIC, WAVE FORMS SENT TO THORATEC. PUMP MAY HAVE BEEN OFF 3-5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283054 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1