BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 4943875 · Received July 27, 2015

    Report

    Report Number
    2031702-2015-00148
    Event Type
    Death
    Date Received
    July 27, 2015
    Date of Event
    March 8, 2015
    Report Date
    July 27, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PERFORMED AN EVENT TRACE DOWNLOAD AND NON-INVASIVE TESTING. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS. THE VENTILATOR PASSED THE LTV FINAL TEST WHICH INCLUDES MANY VENTILATION AND ALARM FUNCTIONS AND ALSO PASSED THE GENERAL CHECKOUT. THIS MDR IS BEING FILED BEYOND THE 30 DAY FILING TIMEFRAME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY FROM NATURAL CAUSES WHILE CONNECTED TO THE VENTILATOR. THE VENTILATOR WAS POWERED OFF WHEN THE CAREGIVER REALIZED THE PATIENT WAS NO LONGER BREATHING. THERE WERE NO ALLEGATIONS OF VENTILATOR MALFUNCTION CAUSING PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486950 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death