BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE

    MDR report key: 2321841 · Received October 30, 2011

    Report

    Report Number
    2321841
    Event Type
    Malfunction
    Date Received
    October 30, 2011
    Date of Event
    October 7, 2011
    Report Date
    October 30, 2011
    Manufacturer
    CAREFUSION
    Product Code
    BYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AIDE WAS ASSISTING PATIENT AND NOTED DIFFICULTY BREATHING. SHE IMMEDIATELY CALLED FOR ASSISTANCE. RN ENTERED ROOM AND ATTEMPTED TO BAG/SUCTION PT VIA TRACH AND MET RESISTANCE. PATIENT HAD SUDDEN, STRONG COUGH AND LARGE WHITE OBJECT WAS EXPELLED FROM TRACH TUBE. AFTER THE OBJECT WAS DISLODGED, THE PATIENT'S REPARATORY STATUS WAS STABLE. EASY EFFORT, GOOD COLORING AND O2 SATS SATURATIONS WERE BASELINE FOR THE PATIENT. AFTER INVESTIGATION OF THE OBJECT, IT WAS DETERMINED THAT THE SPONGE FROM THE TRACH "NOSE" THAT WAS ON THE PATIENT. THE TRACH "NOSE"/HYGROSCOPIC CONDENSER HUMIDIFIER (HCH) WAS AN INFANT MODEL AND THE PT HAD SHILEY 4.0 TRACH, WHICH IS A SMALL ADULT TRACH. WE BELIEVE THIS CONTRIBUTED TO THE SPONGE BECOMING DISLODGED FROM THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE HYGROSCOPIC CONDENSER HUMIDIFIERS BYD CAREFUSION INFANT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR