BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CORP

    MDR report key: 1036097 · Received April 29, 2008

    Report

    Report Number
    MW5006495
    Event Type
    Injury
    Date Received
    April 29, 2008
    Date of Event
    April 26, 2008
    Report Date
    April 29, 2008
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IN CICU ON TLC II DRIVER. MACHINE ALARMED OVERHEAT. SPARE MACHINE IN ROOM WAS EMPLOYED IMMEDIATELY AND NO INJURY TO PT. PT IS FINE AND HAS GONE HOME. ORIGINAL DEVICE SUPPORTED PT THROUGH ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THORATEC CORP HEARTMATE DRIVER DSQ THORATEC CORP TLC II

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability