BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6196595 · Received December 21, 2016

    Report

    Report Number
    2031702-2016-01621
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 21, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION PERFORMED BENCH TESTING ON THE UNIT, AND ALL TESTING WAS PERFORMED USING A GOOD KNOWN TEST PATIENT CIRCUIT AS WELL AS A GOOD KNOWN AC ADAPTER. THE VENTILATOR PASSED 93 HOURS OF EXTENDED TESTS AT THE CUSTOMER¿S SETTINGS. THE VENTILATOR ALSO PASSED THE LTV FINAL TEST WHICH INCLUDES MANY VENTILATION AND ALARM FUNCTIONS. THE UNIT PASSED ALL TESTING'S.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CAREFUSION THAT A PATIENT PASSED AWAY WHILE CONNECTED TO AN LTV 1150 VENTILATOR. THERE ARE CURRENTLY NO ALLEGATIONS THAT THE VENTILATOR CAUSED THE PATIENT DEATH, THE CUSTOMER REPORTED THAT THE GRANDMOTHER OF THE PATIENT STATED THAT THE PATIENT HAD BEEN SICK. THE CUSTOMER SENT THE VENTILATOR TO CAREFUSION TO ASSURE PROPER OPERATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845735 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death