BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGNA HI SPEED 1.5T

    MDR report key: 733006 · Received July 7, 2006

    Report

    Report Number
    2183553-2006-00019
    Event Type
    Other
    Date Received
    July 7, 2006
    Date of Event
    June 8, 2006
    Report Date
    July 7, 2006
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP VERIFIED THAT THE SYSTEM WAS IN USER MODE AND PERFORMED SYSTEM PERFORMANCE TEST (SPT). THE SYSTEM WAS OPERATING WITHIN SPECIFICATION. THE FIRE OCCURRED BECAUSE THE BODY TRANSMIT COIL WAS USED WHILE A TR COIL WAS IN THE BORE. RF ENERGY WAS COUPLED FROM THE BODY TRANSMIT COIL INTO THE TR EXTREMITY COIL, WHICH RESULTED IN HEATING. THE COIL WARMING LABELS AND WORKING SAFETY SECTION OF THE OPERATOR MANUAL SPECIFICALLY WARN ABOUT USING THE BODY TRANSMIT COIL WITH TR SURFACE COILS, SUCH AS THE MEDICAL ADVANCES INC. TR QUAD KNEE COIL. THE MRI SYSTEM IS STILL IN OPERATION AFTER BEING EVALUATED BY THE FE. THE TR COIL WAS RETURNED FOR EVALUATION. ALTHOUGH MEDICAL ADVANCES MANUFACTURES THE KNEE COIL, IT IS SOLD EXCLUSIVELY TO GE. GE IS ALSO NOTIFYING MEDICAL ADVANCES OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MEDICAL ADVANCES, INC. TRANSMIT/RECEIVE QUAD KNEE COIL WAS INVOLVED IN AN EVENT PRESENTING A THERMAL HAZARD TO A PT WHEN AN MRI SCAN USING BODY COIL TRANSMIT WAS PERFORMED WITH THE TR COIL IN THE BORE. THE BLANKET WAS PLACED OVER THE TR COIL AND THE TR COIL HOUSING CAUGHT ON FIRE. THE TECHNOLOGIST EXTINGUISHED THE BLANKET AND THE COIL HOUSING EXTINGUISHED WITHOUT INTERVENTION AFTER ENERGY WAS REMOVED. THE PT WAS EVALUATED BY THE SITE EMERGENCY ROOM AND DID NOT REQUIRE MEDICAL TREATMENT. THE MRI SYSTEM COVERS WERE NOT COMPROMISED BY THIS THERMAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HI SPEED 1.5T MOBILE MR LNG GE MEDICAL SYSTEMS, LLC 2225478 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other