BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAB N' GO VANTAGE VALVE INTEGRATED PRESSURE REGULATOR FOR D OR E CYLINDER COMPA

    MDR report key: 5662241 · Received May 13, 2016

    Report

    Report Number
    MW5062337
    Event Type
    Malfunction
    Date Received
    May 13, 2016
    Date of Event
    May 4, 2016
    Report Date
    May 13, 2016
    Manufacturer
    PRAXAIR DISTRIBUTION, INC.
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A GRAB N' GO VANTAGE VALVE INTEGRATED PRESSURE REGULATOR WAS IN PLACE ON AN ALUMINUM OXYGEN CYLINDER MARKED MR COMPATIBLE. THE TECH NOTED A PULL OF THE CYLINDER FROM REGULATOR TOWARDS THE 1.5 TESLA MRI MAGNET AND WAS ABLE TO PREVENT ITEM FROM BEING DRAWN INTO MAGNET. PRAXAIR DISTRIBUTION, INC., LOGGED THE (B)(4). THE COMPANY USES SHELLOCK MRI SERVICES, INC., TO EVALUATE THEIR PRODUCTS BASED ON ASTMF2503-8 SPECIFICATIONS. THE PRAXAIR AIR GRAB N' GO UNIT WAS TESTED FOR TRANSLATIONS ATTRACTION AT 3 TESLA. KNOWN FERROUS METAL PIN OR C-CLIP. STATES SHOULD NOT HAVE EXPERIENCED PULL. THE TECH NOTICED THE PULL AS ENTERED ZONE 4 OF THE MAGNET ROOM OF 1.5 TESLA. NO INJURY OR DAMAGE TO STAFF, PATIENTS OR MAGNET OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307518 GRAB N' GO VANTAGE VALVE INTEGRATED PRESSURE REGULATOR FOR D OR E CYLINDER COMPA OXYGEN REGULATOR CAN PRAXAIR DISTRIBUTION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other