BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL F2 BREATHING CIRCUIT

    MDR report key: 545528 · Received July 29, 2004

    Report

    Report Number
    MW1032867
    Event Type
    Malfunction
    Date Received
    July 29, 2004
    Date of Event
    July 21, 2004
    Report Date
    July 21, 2004
    Manufacturer
    KING SYSTEMS CORP
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT NOTED TO HAVE A HIGH CONCENTRATION OF CO2 INSPIRED. TROUBLE SHOOTING CAUSE UNCOVERED INTERNAL DISCONNECT OF COAXIAL VENTILATOR TUBING AT PROXIMAL END. VENTILATOR AND TUBING PASSED THE FDA CHECKLIST PRIOR TO CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL F2 BREATHING CIRCUIT VENTILATOR TUBING BZO KING SYSTEMS CORP F2 18L22

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR