BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIMS PORTEX INC.

    MDR report key: 840845 · Received April 20, 2007

    Report

    Report Number
    MW5001824
    Event Type
    Other
    Date Received
    April 20, 2007
    Date of Event
    April 20, 2007
    Report Date
    April 20, 2007
    Manufacturer
    SIMS PORTEX INC.
    Product Code
    BZO
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AEROSOL DRAINAGE BAG - PORTEX PART 001573- WAS CONNECTED IMPROPERLY. A SIDE VALVE IS THE SAME DIAMETER AS THE TUBING ATTACHMENT PORTS, AND AEROSOL TUBING WAS MISTAKENLY PLACED ON THE VALVE, DEPRIVING THIS -TRACHEOTOMIZED- PT OF 40% OXYGEN. NO KNOWN INJURY OCCURRED IN THIS INSTANCE, BUT THE PT'S OXYGEN SATURATION FELL TO LESS THAN 90%, ACCORDING TO THE RESPIRATORY THERAPIST ON DUTY AT THAT TIME. DURING THE NIGHT SHIFT, EARLY IN 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMS PORTEX INC. FIRST BREATH DRAINAGE BAG -3L- AERO TRACH UNIT BZO SIMS PORTEX INC. 001573

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR