BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2914463 · Received January 14, 2013

    Report

    Report Number
    2914463
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 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

    DISPLAY CONNECTED TO PT SYSTEM CONTROLLER IN CLINIC READ IN THE 120'S. THE PI ON HOSPITAL MONITOR READ 12.5. WITH THE PT LYING FLAT, THE SYSTEM CONTROLLER WAS REPLACED. THEN THE PI WAS DOWN TO 5.5. NEW BACKUP CONTROLLER ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20153 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1