BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 850665 · Received May 4, 2007

    Report

    Report Number
    850665
    Event Type
    Injury
    Date Received
    May 4, 2007
    Date of Event
    April 29, 2007
    Report Date
    May 3, 2007
    Manufacturer
    RESONANCE TECHNOLOGY, INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US

    Narratives

    Description of Event or Problem · 1

    MRI STAFF REPORTED THAT INPATIENT WAS SITUATED ON TABLE W/6 LITERS OXYGEN. PATIENT WAS CALM AND TALKING. A 20SEC SCOUT WAS COMPLETED AND FOLLOWED BY A 3MIN 11SEC SCAN. FAN WAS ON LOW. MRI TECH NOTICED THAT PATIENT SEEMED AGITATED. SHE IMMEDIATELY STOPPED SCAN, WENT INTO ROOM AND SAW A SMALL AMOUNT OF CIRCLING SMOKE INSIDE SCANNER BORE. PULLED PATIENT OUT, RIPPED OFF BLANKET AND GOWN. WHEN GOWN WAS PULLED, A SMALL OBJECT FELL OUT. IT APPEARED TO BE A WATCH OR HEARING AID BATTERY. THE GOWN AND BLANKET WERE SCORCHED AROUND THE NECK AREA. THE PATIENT HAD A BURN/RED AREA OF SKIN (QUARTER SIZE)AT THE STERNAL NOTCH AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MRI, HEADSET, AUDIO LNH RESONANCE TECHNOLOGY, INC. RTC2K *
    2 MAGNETOM MAESTRO IMAGING SYSTEM, MRI LNH SIEMENS MEDICAL SOLUTIONS USA, INC. * *
    3 * TRANSDUCER LNH RESONANCE TECHNOLOGY, INC. XAA-RTC2K *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R OTHER