BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6031726 · Received October 14, 2016

    Report

    Report Number
    2031702-2016-01083
    Event Type
    Death
    Date Received
    October 14, 2016
    Date of Event
    September 13, 2016
    Report Date
    September 16, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: (B)(4) PERFORMED BENCH TESTING ON THE UNIT. ALL TESTING WAS PERFORMED USING A GOOD KNOWN TEST AC ADAPTER AS WELL AS A GOOD KNOWN TEST PATIENT CIRCUIT. THE VENTILATOR PASSED 71 HOURS OF EXTENDED TESTS AT THE CUSTOMER¿S SETTINGS. THE VENTILATOR FAILED THE FINAL TEST FOR SLIGHT NON CONFORMITIES WITH HIGH TIDAL VOLUMES. THIS SLIGHT NON-CONFORMITY WILL NOT AFFECT THE WAY THE VENTILATOR VENTILATES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO (B)(4) THAT THERE WAS A PATIENT DEATH. THE CUSTOMER STATED THAT THE PATIENT WAS FOUND DISCONNECTED FROM THE VENTILATOR AND THE VENTILATOR WAS ALARMING. AS A PRECAUTION, THE CUSTOMER WANTS TO MAKE SURE THE UNIT ALARMED AND FUNCTIONED PROPERLY AND REQUESTED THE VENTILATOR BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681305 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death