BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1000 VENTILATOR

    MDR report key: 6010098 · Received October 6, 2016

    Report

    Report Number
    2031702-2016-01029
    Event Type
    Death
    Date Received
    October 6, 2016
    Date of Event
    September 11, 2014
    Report Date
    November 15, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION PERFORMED BENCH TESTING ON THE UNIT. ALL TESTING WAS PERFORMED USING A KNOWN GOOD TEST PATIENT CIRCUIT AS WELL AS A KNOWN GOOD AC ADAPTER. THE VENTILATOR PASSED 91 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 THE CALCULATED TIDAL VOLUME AVERAGE. THESE SLIGHT NON-CONFORMITIES WOULD NOT RESULT IN A FAILURE TO VENTILATE PROPERLY. THE CUSTOMER REFUSED REPAIRS AND REQUESTED THE RETURNED OF THE VENTILATOR UNREPAIRED. THIS VENTILATOR IS NOT FOR PATIENT USE UNTIL APPROPRIATE REPAIRS AND TESTING'S ARE COMPLETED.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT B4 IS INTENDED TO BE LEFT BLANK BUT BECOMES AUTO POPULATED AFTER SUBMISSION, AS A RESULT OF A SOFTWARE RELATED ANOMALY THAT IS BEING ADDRESSED. PLEASE DISREGARD THE DATE ENTERED IN SECTION B4. 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 WAS IN A FACILITY WITH THE RESPIRATORY THERAPIST IN THE ROOM AND THE VENTILATOR STARTED ALARMING. A CODE BLUE WAS CALLED AND THE PATIENT WAS REMOVED FROM THE VENTILATOR AND CPR WAS ADMINISTERED. THERE WERE NO ALLEGATION OF A MALFUNCTION WITH THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656967 LTV 1000 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1 Death