BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYLINDER VALVE

    MDR report key: 1327337 · Received February 25, 2009

    Report

    Report Number
    MW5010104
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    February 17, 2009
    Report Date
    February 25, 2009
    Manufacturer
    CEODEUX, INC., ULTRAPURE EQUIPMENT TECHNOLOGY S.A.
    Product Code
    ECX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A RESPIRATORY THERAPIST WAS EXCHANGING AN OUTPATIENT'S "E" OXYGEN CYLINDER FOR A REFILLED CYLINDER. AS THE THERAPIST WAS TURNING THE VALVE STEM TO OPEN THE CYLINDER, THE OXYGEN VALVE STEM SUDDENLY POPPED OUT HITTING THE CEILING AT A HIGH VELOCITY MISSING THE THERAPIST. THE OXYGEN VALVE HAD IDENTIFYING MARKS OF CEODEUX. DATES OF USE: 2009. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYLINDER VALVE POST TYPE CYLINDER VALVE FOR OXYGEN ECX CEODEUX, INC., ULTRAPURE EQUIPMENT TECHNOLOGY S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening