BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1000 VENTILATOR

    MDR report key: 6042593 · Received October 19, 2016

    Report

    Report Number
    2031702-2016-01142
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    October 28, 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

    AS A RESULT OF A SOFTWARE RELATED ANOMALY THAT IS BEING ADDRESSED. PLEASE DISREGARD THE DATE ENTERED. 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.

    Additional Manufacturer Narrative · 1

    ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4). CAREFUSION CERTIFIED SERVICE TECHNICIAN EVALUATED MODEL LAP TOP VENTILATOR 950. THE UNIT PASSED ALL TESTING AND MET ALL CAREFUSION MANUFACTURER SPECIFICATIONS. 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

    THE CUSTOMER REPORTED A PATIENT WAS FOUND UNRESPONSIVE AND DISCONNECTED FROM MODEL LAP TOP VENTILATOR 950. THE PATIENT'S CAREGIVER WAS AWAKENED BY THE SOUND OF THE VENTILATOR ALARMING. EMERGENCY RESPONSE WAS CALLED IMMEDIATELY. THEY ARRIVED WITHIN MINUTES BUT WERE UNABLE TO REVIVE THE MALE PATIENT. THE CUSTOMER CONFIRMED THERE ARE NO ALLEGATIONS OF VENTILATOR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690120 LTV 1000 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 950 VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death