BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGA LINDE HEALTHCARE

    MDR report key: 361326 · Received October 31, 2001

    Report

    Report Number
    361326
    Event Type
    Malfunction
    Date Received
    October 31, 2001
    Date of Event
    October 15, 2001
    Report Date
    October 29, 2001
    Manufacturer
    AGA GAS, INC
    Product Code
    BYJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED WHEN A MRI TECH ENTERED THE MRI PROCEDURE ROOM WITH WHAT WAS LABELED AS A MRI COMPATIBLE O2 TANK. THE TECH AND O2 TANK WERE PULLED INTO MAGNET. O2 TANK WAS LABELED "GREEN TOP, GRAY BOTTOM." "MRI SAFE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48714 AGA LINDE HEALTHCARE MRI SAFE O2 TANK BYJ AGA GAS, INC 12101J1051AE *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other