BEUDAMED
    FDA Adverse Event Other Summary report: N

    GE SIGNA LX90

    MDR report key: 455846 · Received April 3, 2003

    Report

    Report Number
    455846
    Event Type
    Other
    Date Received
    April 3, 2003
    Date of Event
    March 27, 2003
    Report Date
    March 28, 2003
    Manufacturer
    MEDICAL ADVANCES INC
    Product Code
    MOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING AN MRI SCAN OF THE PT'S KNEE AND UNDER ANESTHESIA, AN ELECTRICAL OVERLOAD OCCURRED. THERE WAS A SPARK AND ENOUGH HEAT TO BURN A HOLE IN THE RF COIL. THE PT WAS ON 100% OXYGEN WHEN THE EVENT HAPPENED. NO HARM WAS DONE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE SIGNA LX90 MRJ EXTREMITY COIL MOS MEDICAL ADVANCES INC 472GE-64 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other