BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1000 VENTILATOR

    MDR report key: 6085888 · Received November 8, 2016

    Report

    Report Number
    2031702-2016-01340
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    June 29, 2014
    Report Date
    November 8, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION PERFORMED BENCH TESTING ON THE UNIT. ALL TESTING WAS PERFORMED USING A KNOWN TEST PATIENT CIRCUIT. THE VENTILATOR PASSED 95 HOURS OF EXTENDED TESTS AT THE CUSTOMER'S SETTINGS. THE VENTILATOR FAILED THE LTV FINAL TEST FOR NON-CONFORMITIES WITH THE FLOW PERFORMANCE TEST AND CALCULATED TIDAL VOLUME AVERAGE. THESE SLIGHT NON-CONFORMITIES WOULD NOT RESULT IN A FAILURE TO VENTILATE PROPERLY. THIS COMPLAINT WAS INCLUDED IN A TWO-YEAR RETROSPECTIVE COMPLAINT REVIEW TO ASSESS MDR REPORTABILITY COMPLIANCE. THIS COMPLAINT WAS DEEMED TO MEET THE REQUIREMENTS FOR MDR SUBMISSION AND IS THEREFORE BEING SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED TO CAREFUSION THAT THE PATIENT PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THE FAMILY IS ALLEGEDLY PROSECUTING THE NURSING AGENCY AND THERE IS A POLICE INVESTIGATION. THERE WERE NO ALLEGATIONS OF THE VENTILATOR MALFUNCTIONING OR CAUSING PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736266 LTV 1000 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 900

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death