BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV

    MDR report key: 4900145 · Received July 8, 2015

    Report

    Report Number
    2031702-2015-00125
    Event Type
    Death
    Date Received
    July 8, 2015
    Date of Event
    May 16, 2015
    Report Date
    July 8, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS AND PASSED ALL ALARM TESTING. DURING THE LTV FINAL TEST, THE VENTILATOR HAD SLIGHT NON-CONFORMANCES WITH THE FLOW PERFORMANCE TEST AND THE CALCULATED VTI AVERAGE. THESE SLIGHT NON-CONFORMANCES WOULD NOT RESULT IN A FAILURE TO VENTILATE PROPERLY. THE FLOW VALVE WAS REPLACED TO CORRECT THE SLIGHT NON-CONFORMANCES THAT WERE FOUND DURING SERVICE OF THE VENTILATOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DE-SATURATED WHILE ON THE VENTILATOR. THE PATIENT WAS TAKEN OFF OF THE VENTILATOR AND, ACCORDING TO THE PATIENT'S MOM, THE RN FAILED TO MANUALLY VENTILATE THE PATIENT. IT IS UNKNOWN IF THE VENTILATOR HAD AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. AN AMBULANCE TOOK THE PATIENT TO THE HOSPITAL WHERE THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443875 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Death