BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE PREFILLED NEBULIZER KIT

    MDR report key: 5916966 · Received August 31, 2016

    Report

    Report Number
    5916966
    Event Type
    Malfunction
    Date Received
    August 31, 2016
    Date of Event
    May 11, 2016
    Report Date
    August 17, 2016
    Manufacturer
    CAREFUSION 211, INC. DBA CAREFUSION
    Product Code
    CAF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ON TRACH MASK, FOR THE FIRST TIME TODAY ON THE AIRLIFE NEBULIZER KIT (TRACH MASK SET UP). THE DEVICE SEEMED TO HAVE A FACTORY DEFECT AND STOPPED DELIVERING OXYGEN TO THE PATIENT, IN WHICH HE DESATURATED TO 82% AND BECAME AGITATED. I KNEW WHAT HAD HAPPENED RIGHT AWAY AND PLACED HIM ON THE VENTILATOR (AT BEDSIDE) IMMEDIATELY AND HYPER-OXYGENATED HIM. I REPLACED THE DEVICE AND CONTINUED HIM ON A NEW AIRLIFE NEBULIZER KIT. I HAVE SEEN THIS MANUFACTURER DEFECT ON ONE OF THE DEVICES BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569805 AIRLIFE PREFILLED NEBULIZER KIT NEBULIZER (DIRECT PATIENT INTERFACE) CAF CAREFUSION 211, INC. DBA CAREFUSION 1000ML Z1-1512262

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other