BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 644999 · Received October 21, 2005

    Report

    Report Number
    644999
    Event Type
    Other
    Date Received
    October 21, 2005
    Date of Event
    September 29, 2005
    Report Date
    October 19, 2005
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    DURING A LENGTHY SCAN INVOLVING ANESTHESIA, THE PATIENT WAS REPORTEDLY BURNED DURING THE EXAM ON THE ELBOW. THE MRI STAFF HAD BEEN INSTRUCTED BY THE PHYSICIAN TO PAD UNDER THE PATIENT'S ARMS AND A SHEET WAS ALSO WRAPPED AROUND THE PADS AND ARMS SO THAT THE PATIENT'S ARMS WERE NOT TOUCHING THE SCANNER. PATIENT WAS BROUGHT OUT OF THE SCANNER SEVERAL TIMES DURING THE SCAN AND ASSESSED FOR MONITORING PURPOSES. THE SCAN WAS BEGUN AT 1010 AND ENDED AT 1300. DURING THE SCAN, THE EKG LEADS THAT WERE ATTACHED TO THE PATIENT MALFUNCTIONED AND WERE REPLACED BY ANOTHER SET. THE MALFUNCTIONING CABLE WAS ROLLED UP AND PLACED AT THE PATIENT'S HEAD FOR THE REMAINING TIME OF THE SCAN. THE REST OF THE CABLE WAS LEFT INSIDE THE BORE WITH THE PATIENT. THE PATIENT ALSO BEGAN SWEATING PROFUSELY AND SOME OF THE SHEETS AND BLANKETS AROUND THE PATIENTS WERE REMOVED AT THAT TIME. THE STUDIES THE PATIENT UNDERWENT INCLUDED LUMBAR SPINE AND PELVIS BOTH DONE WITH AND WITHOUT CONTRAST. THE MRI SCANNER WAS EVALUATED AFTER THE PROCEDURE BY THE MANUFACTURER AND DETERMINED TO BE FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MRI SCANNER LNH GE MEDICAL SYSTEMS, LLC 2255236 REV. 8 R0771 *
    2 * EKG CABLES MLN INVIVO RESEARCH, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *