BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIVERSAL BAG REFILL VALVE

    MDR report key: 300828 · Received October 17, 2000

    Report

    Report Number
    300828
    Event Type
    Death
    Date Received
    October 17, 2000
    Date of Event
    October 7, 2000
    Report Date
    October 11, 2000
    Manufacturer
    ALLIED HEALTH PRODUCTS, INC. LIFE SUPPORT PRODUCTS, INC.
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Description of Event or Problem · 1

    THE PT WAS TRANSFERRED VIA EMERGENCY MEDICAL SYSTEM WHILE INTUBATED, USING THE BAG REFILL VALVE BELOW. WHEN THE PT ARRIVED IN THE EMERGENCY DEPT, THE TUBING FROM THE BAG-VALVE-MASK WAS CONNECTED TO A WALL SOURCE OF OXYGEN, WHILE STILL CONNECTED TO THE BAG REFILL VALVE. THIS PARTICULAR BAG REFILL VALVE DOES NOT HAVE A RELIEF VALVE AND SUBSEQUENTLY ALL THE OXYGEN FROM THE TANK AND THE WALL WAS FORCED INTO THE PT'S BODY RATHER THAN BEING RELEASED. RPTR HAS SEEN THAT A NEWER MODEL OF THESE REFILL VALVES ARE MADE AND HAS THOSE AS WELL, BUT THE DIFFERENCE IN THEM IS THAT THE NEW ONES HAVE A RELIEF VALVE THAT PREVENTS THE AIR FROM BEING FORCED INTO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL BAG REFILL VALVE BAG REFILL VALVE BTM ALLIED HEALTH PRODUCTS, INC. LIFE SUPPORT PRODUCTS, INC. 470 OR 471 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death