BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURORA 1.5T BREAST MRI

    MDR report key: 3653230 · Received January 31, 2014

    Report

    Report Number
    3653230
    Event Type
    Injury
    Date Received
    January 31, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 26, 2014
    Manufacturer
    AURORA IMAGING TECHNOLOGY, INC.
    Product Code
    LHN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A NON MRI SAFE OXYGEN TANK WAS DELIVERED BY THE VENDOR IN ERROR AND WAS PLACED IN THE MRI SUITE IN ERROR. THE TECHNOLOGIST MOVED THE TANK SIZE "E" TO GIVE THE PT OXYGEN SHE HEARD THE TANK MOVE AND GRABBED IT AS IT BEGAN TO GO TOWARD THE MAGNET. SHE WAS ABLE TO HOLD ONTO THE TANK ON THE SIDE OF THE MAGNET AS THE PT WAS REMOVED FROM THE PHYSICIAN AND STAFF. THE MAGNET WAS QUENCHED. THE REGULATOR HIT THE PT IN THE LEFT UPPER ARM AS IT WENT TO THE SIDE OF THE MAGNET CAUSING A LACERATION, THE PT WAS TRANSPORTED TO THE HOSPITAL FOR STITCHES. THE PT WILL FULLY RECOVER. THE MRI SUITE BECAME FILLED WITH A CLOUD OF HELIUM AT THE CEILING AND BEGAN TO MOVE DOWN TOWARDS THE STAFF. THE BUILDING WAS EVACUATED UNTIL THE FIRE DEPT DETERMINED THE AIR QUALITY WAS SAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66817 AURORA 1.5T BREAST MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE LHN AURORA IMAGING TECHNOLOGY, INC. 01-04475-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization