BEUDAMED
    FDA Adverse Event Summary report: N

    AIRLIFE BIRD OMNIBLENDER

    MDR report key: 3072437 · Received April 16, 2013

    Report

    Report Number
    3072437
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CARE FUSION 2200, INC.
    Product Code
    BZE
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN NOTICED WATER IN THE OXYGEN BLENDER ATTACHED TO THE VENTILATOR IN THE NICU. THE VENTILATOR WAS NOT CONNECTED TO A PATIENT AT THE TIME. NO PATIENT HARM OCCURRED. THE WATER WAS NOTICED WHEN THE VENTILATOR WAS BEING CHECKED AS PART OF ROUTINE DAILY INSPECTION- IT WAS NOT ON A PATIENT. THE CAUSE OF THIS EVENT WAS WATER LEAKING INTO THE MEDICAL AIR LINE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REGULATE THE AMOUNT OF OXYGEN AND AIR GOING INTO THE VENTILATOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163271 AIRLIFE BIRD OMNIBLENDER HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR BZE CARE FUSION 2200, INC. 03803T *

    Patients

    Seq Age Sex Outcome Treatment
    1 *