BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6153251 · Received December 7, 2016

    Report

    Report Number
    2031702-2016-01593
    Event Type
    Death
    Date Received
    December 7, 2016
    Date of Event
    March 18, 2014
    Report Date
    December 7, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: CAREFUSION PERFORMED BENCH TESTING ON THE UNIT. THE VENTILATOR PASSED 95 HOURS OF EXTENDED TESTS AT THE CUSTOMER'S SETTINGS. THE VENTILATOR PASSED THE LTV FINAL TEST WHICH INCLUDES MANY VENTILATION AND ALARM FUNCTIONS. 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 UNDER NORMAL CIRCUMSTANCES WHILE CONNECTED TO THE VENTILATOR. THE CUSTOMER STATED THAT THE PULSE OXIMETER ALARMED AS INTENDED WHEN THE HEART RATE DECREASED. THE MEDICAL EXAMINER RULED THE DEATH DUE TO NATURAL CAUSES. THERE WERE NO VENTILATOR ISSUES NOTED BY THE RESPIRATORY THERAPIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801485 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death