BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE VOLUME VENTILATOR CIRCUIT

    MDR report key: 3962730 · Received July 22, 2014

    Report

    Report Number
    3962730
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 22, 2014
    Manufacturer
    CAREFUSION 303, INC.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    WHILE REPOSITIONING PATIENT ALLOWING FOR ROOM FOR VENTILATOR TUBING SLACK, VENT CIRCUIT BECAME SUDDENLY AND FORCEFULLY DISCONNECTED FROM THE VENT FILTER -- SPRAYING A MIST OF CONDENSATION ONTO NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427084 AIRLIFE VOLUME VENTILATOR CIRCUIT SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) BZO CAREFUSION 303, INC. * SJ0214008

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR REF # D/X800| YES. HUDSON RCI VENTILATOR CIRCUIT REF # 780-32,| 03EU, LOT # 7753314, COVIDIEN PURITAN BENNETT,| GE BACTERIAL/VIRAL FILTER "RESPIRGARD II", REF # 3