BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE MISTY FINITY

    MDR report key: 6056689 · Received October 26, 2016

    Report

    Report Number
    6056689
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    September 23, 2016
    Report Date
    October 17, 2016
    Manufacturer
    CAREFUSION 211, INC.. DBA CAREFUSION
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTICED THAT AT ONE HOUR INTO A NEBULIZER THERAPY IT WAS TAKING ALMOST TWO HOURS TO COMPLETE. OUR ORGANIZATION'S STAFF TESTED FOUR OTHER NEBULIZERS AND THEY DID NOT NEBULIZE WITHIN SPECIFICATIONS. SPECIFICATIONS ARE +/- 20%. THE ONES THAT WERE MALFUNCTIONING WERE +/- 30-50%. WE WERE ABLE TO PINPOINT IT TO ONE LOT OF PRODUCT BECAUSE WE TESTED FIVE OTHER NEBULIZERS WITH OTHER LOT NUMBERS AND THEY ALL FUNCTIONED WITHIN SPECIFICATIONS. MANUFACTURER IS AWARE. THEY REPLACED THE NEBULIZERS WITH A DIFFERENT LOT NUMBER AND WILL COMPLETE THEIR TESTING AFTER WE RETURN THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709198 AIRLIFE MISTY FINITY NEBULIZER, CONTINUOUS CAF CAREFUSION 211, INC.. DBA CAREFUSION 110970

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR NO