BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6061051 · Received October 27, 2016

    Report

    Report Number
    2031702-2016-01207
    Event Type
    Death
    Date Received
    October 27, 2016
    Date of Event
    November 29, 2014
    Report Date
    October 27, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    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 TESTED MODEL LAP TOP VENTILATOR 1150. 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 THAT A MALE PATIENT EXPIRED WHILE CONNECTED TO MODEL LAP TOP VENTILATOR 1150. THERE ARE NO ALLEGATIONS OF VENTILATOR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712164 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 1150 VENTILATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Death