BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 3760762 · Received April 1, 2014

    Report

    Report Number
    3760762
    Event Type
    Malfunction
    Date Received
    April 1, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    CAREFUSION 211, INC.. DBA CAREFUSION
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    THE HUMIDIFIER WAS CONNECTED TO AN OXYGEN FLOWMETER, AT 2 LPM. THE RESPIRATORY THERAPIST NOTED BUBBLES COMING THROUGH THE WATER JAR, HOWEVER THERE WAS NO OXYGEN FLOW OUT OF THE DEVICE. THE JAR TO HEAD ASSEMBLY SCREW CONNECTION APPEARS TO BE LEAKING. AN ADDITIONAL UNIT WAS TESTED AND MALFUNCTIONED IN THE SAME MANNER.======================MANUFACTURER RESPONSE FOR BUBBLE HUMIDIFIER, AIRLIFE (PER SITE REPORTER).======================NO RESPONSE AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193408 AIRLIFE HUMIDIFIER BTT CAREFUSION 211, INC.. DBA CAREFUSION * 0000564949

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO OTHER THERAPIES