BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5T SIEMENS ESPREE MRI

    MDR report key: 3896269 · Received June 20, 2014

    Report

    Report Number
    MW5036819
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MRI UNIT WAS EVALUATED BY MANUFACTURER AND FSE OF CONTRACT COMPANY AS WITHIN SPECIFICATIONS ON (B)(6) 2014. ON (B)(6) 2014 A LUMBAR SPINE SCAN WAS BEING PERFORMED EARLY AM. AFTER INITIAL SCOUT IMAGES, T1 SAGITTAL AND T1 AXIAL SCAN WERE PERFORMED THE SUBJECT FELT NORMAL WARMING OF THE BODY PART BEING SCANNED. T2 SAGITTAL AND STIR SAGITTAL SEQUENCES PERFORMED. T2 AXIAL IMAGING STARTED AND IN MID-SCAN SUBJECT ASKED FOR THE SCAN TO BE TERMINATED FOLLOWING A FEELING REASSEMBLING A "TASER" BEING USED ON THE LOWER RIGHT LUMBAR AREA. OVERHEATING OF THE SKIN AND PAIN WAS FELT ALONG WITH ERYTHEMA AND AN AREA OF 2.4CM X 1.1CM DIAGNOSED TO BE 2ND DEGREE BURN OF PARTIAL THICKNESS. EXAMINATION TERMINATED, RADIOLOGIST NOTIFIED. SUBJECT EVALUATED AND FOUND TO INDEED HAVE A 2ND DEGREE BURN THAT WAS NOT PRESENT BEFORE THE MRI EXAMINATION. NOTICE OF INJURY REPORTED TO FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364081 1.5T SIEMENS ESPREE MRI MRI LNH SIEMENS MEDICAL SOLUTIONS USA, INC. 76X18 I-CLASS TIM

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other