BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AURORA 1.5T BREAST MRI

    MDR report key: 3653116 · Received January 30, 2014

    Report

    Report Number
    1225267-2014-00001
    Event Type
    Injury
    Date Received
    January 30, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 24, 2014
    Manufacturer
    AURORA IMAGING TECHNOLOGY, INC.
    Product Code
    LNH
    PMA / PMN Number
    K052698
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT RESULTED FROM AN OPERATOR INADVERTENTLY BRINGING A FERROUS GAS CYLINDER INTO THE MRI EXAM ROOM. MRI SAFETY WARNINGS SIGNS WERE PRESENT AT THE ENTRANCE TO THE EXAM ROOM. AURORA OPERATOR'S DOCUMENTATION COVERS MAGNET SAFETY ISSUES, INCLUDING THE ENTRY OF ANY AND ALL FERROUS OBJECTS TO THE EXAM OR MAGNET ROOMS. AURORA WAS INFORMED THAT VICTORY PERSONNEL WERE RECENTLY PROVIDING REFRESHER IN-SERVICE TRAINING WHICH COVERED THE POSSIBILITY OF FERROUS OBJECTS BECOMING PROJECTILES. (B)(4).

    Description of Event or Problem · 1

    THE MRI TECHNOLOGIST CALLED AURORA SERVICE AT 9:37AM EST TO REPORT A GAS CYLINDER WAS DRAWN INTO THE BORE OF THEIR AURORA 1.5T BY THE MAGNETIC FIELD, INJURING A PT THEREIN. AS IT HAS BEEN RELATED TO US, THIS OCCURRED WHEN THE MRI TECHNOLOGIST BROUGHT THE SMALL GAS CYLINDER TOWARD THE MAGNET, ATTENDING TO THE PT RESENT IN THE MAGNET BORE. THE CYLINDER WAS PULLED INTO THE MAGNET BORE. THE CYLINDER WAS PULLED INTO THE MAGNET AS THE TECHNOLOGIST STRUGGLED TO KEEP IT FROM INJURING THE PT, BUT IT GOT AWAY AND BECAME ATTACHED TO THE MAGNET. THE TECHNOLOGIST MOVED QUICKLY TO ACTIVATE THE EMERGENCY QUENCH BUTTON TO DE-ENERGIZE THE MAGNET. THE INJURED PT, WHO HAD LACERATIONS ON HER LEFT ARM FROM THE GAS REGULATOR ON THE CYLINDER, WAS REMOVED FROM THE MAGNET AND CONVEYED BY AMBULANCE TO A LOCAL HOSPITAL FOR TREATMENT OF THE INJURY. IT WAS REPORTED THAT THE LACERATIONS REQUIRED SUTURES TO CLOSE. THE EMERGENCY MAGNET DISCHARGE BUTTON WORKS AS IT SHOULD, AND VENTING OF THE HIGH-VOLUME OF HELIUM GAS FORMED WAS SATISFACTORY - A SMALL AMOUNT OF HELIUM VAPOR ESCAPED INTO THE UPPER THIRD OF THE MAGNET ROOM VOLUME AND QUICKLY DISSIPATED, PRESENTING NO UNSAFE CONDITION FOR THE OCCUPANTS OF THAT SPACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64620 AURORA 1.5T BREAST MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH AURORA IMAGING TECHNOLOGY, INC. 01-04475-02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L