BEUDAMED
    FDA Adverse Event Other Summary report: N

    E360 VENTILATOR

    MDR report key: 1011976 · Received March 10, 2008

    Report

    Report Number
    2023050-2008-00014
    Event Type
    Other
    Date Received
    March 10, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 12, 2008
    Manufacturer
    NEWPORT MEDICAL INSTRUMENTS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED FOR EVAL AS THIS IS NOT A DEVICE MALFUNCTION, BUT A USER SET UP ERROR. A REVIEW OF THIS EVENT BY OUR CLINICIAN SHOWED THE USE OF AN HME FILTER COULD BE THE CAUSE OF THE REPORTED HIGH CO2 VALUES. THIS TYPE OF FILTER IS NOT RECOMMENDED FOR USE ON PTS, SUCH AS NEWBORNS, WITH A SMALL LUNG CAPACITY. IT INCREASES THE POSSIBILITY OF REBREATHING, WHICH RESULTS IN HIGH CO2 LEVELS.

    Description of Event or Problem · 1

    (B) (4). AS REPORTED, A NEWBORN, AFTER 1 OR 2 HRS ON THIS UNIT, HAD HIGH VALUES OF CO2 VERIFIED WITH ARTERIAL GASOMETRIC VALUES. INCREASING VALUES, EVEN, WITH HIGH RESPIRATORY RATES WERE REPORTED. WHEN THEY CHANGED TO DIFFERENT VENTILATOR, THE VALUES OF CO2 RETURN TO A NORMAL VALUE WITH THE SAME VENTILATOR SETTINGS. AN HME FILTER WAS BEING USED DURING THIS INCIDENT. PLEASE NOT THERE WAS NO PT INJURY OR DEATH IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E360 VENTILATOR VENTILATOR CBK NEWPORT MEDICAL INSTRUMENTS, INC. E360 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK