BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNA LX 1.5T

    MDR report key: 766722 · Received October 4, 2006

    Report

    Report Number
    2183553-2006-00030
    Event Type
    Other
    Date Received
    October 4, 2006
    Date of Event
    September 27, 2006
    Report Date
    October 4, 2006
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED ON SITE SIGNA SYSTEM TESTS. THE POWER MONITOR FUNCTIONAL CHECKS, POWER OUTPUT CHECK, BASIC SCAN FUNCTIONAL TEST, CTL SNR TEST, AND SPT WERE ALL TESTED SUCCESSFULLY. THE SYSTEM WAS PUT BACK INTO SERVICE. COIL WARNING LABELS AND THE WORKING SAFETY SECTION OF THE OPERATOR'S MANUAL WARN AGAINST THE USE OF BODY COIL TRANSMIT WHEN COILS ARE IN THE BORE. MEDICAL ADVANCES, INC HAS BEEN NOTIFIED OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TRANSMIT/RECEIVE QUAD KNEE COIL MANUFACTURED BY MEDICAL ADVANCES, INC. WAS DAMAGED WEN A BLANKET COVERING THE COIL CAUGHT FIRE. AN ANKLE SCAN USING THE KNEE/FOOT COIL HAD BEEN SUCCESSFULLY COMPLETED. THE SITE THEN BEGAN A LOWER LEG SCAN USING THE SIGNA BODY COIL TRANSMIT. THE ANKLE COIL WAS NOT REMOVED FROM THE BORE, PRIOR TO INITIATING THE LOWER LEG SCAN. THE PT'S FOOT REMAINED IN THE KNEE/FOOT COIL, WHICH WAS PLUGGED INTO THE LPCA AND COVERED BY A BLANKET. THE BLANKLET IGNITED AND WAS EXTINGUISHED BY THE TECHNOLOGIST. THE PT DID NOT REQUIRE MEDICAL TREATMENT AND AN INJURY WAS NOT REPORTED. THE MRI SYSTEM COVERS WERE NOT COMPROMISED BY THIS THERMAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA LX 1.5T MR LNH GE MEDICAL SYSTEMS, LLC 2226300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR