BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUSORB MRI

    MDR report key: 3689554 · Received March 7, 2014

    Report

    Report Number
    3689554
    Event Type
    Injury
    Date Received
    March 7, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MWT MATERIALS, INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS BROUGHT TO MRI FOR A SCAN OF HER RIGHT FOOT. HER RIGHT FOOT WAS PLACED IN THE NECK COIL MATRIX. HER LEFT LEG WAS WRAPPED IN AN RF BLANKET AND HER LOWER LEG WAS RESTING ON THE CORD THAT PLUGS THE NECK COIL MATRIX INTO THE MACHINE. SHE WENT INTO THE MRI FEET FIRST. DURING THE EXAM THE PATIENT STOPPED THE STUDY STATING THAT SHE HAD WHAT FELT LIKE A CRAMP IN HER LEFT LEG. THE TECHNOLOGIST ENTERED THE ROOM AND NOTICED THE SMELL OF SMOKE. WITH THE HELP OF ANOTHER TECHNOLOGIST, HE BEGAN MOVING THE PATIENT OUT OF THE ROOM, THINKING SOMETHING WAS WRONG WITH THE MRI MACHINE. HE DISCOVERED THE RF BLANKET AND THE SOCK THE PATIENT WAS WEARING HAD A BURN HOLE IN THEM, AND THE PATIENT HAD A SECOND DEGREE BURN ON HER HEEL AND POSTERIOR ANKLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139749 ACCUSORB MRI SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING, RF BLANKET LNH MWT MATERIALS, INC. MAC-7001M-01 *
    139750 MEGNETOM TRIO SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH MWT MATERIALS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R SOCKS. SHE WAS IN THE 3T MAGNET (TRIO).| SHE WAS WEARING MEDI-CHOICE NON-SLIP HOSPITAL