BEUDAMED
    FDA Adverse Event Other Summary report: N

    GYROSCAN ACS-NT

    MDR report key: 286409 · Received July 20, 2000

    Report

    Report Number
    MW1019334
    Event Type
    Other
    Date Received
    July 20, 2000
    Date of Event
    June 11, 2000
    Report Date
    July 14, 2000
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
    Product Code
    LNH
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MRI SCAN OF THE PT'S BRAIN WAS PERFORMED. THE EXAM WAS COMPLETED WITHOUT INCIDENT. THE FOLLOWING DAY THE PT NOTICED A RED ELONGATED MARK ACROSS THE UPPER RIGHT SHOULDER AND BELOW PT'S NECK. THE AREA WAS BRIGHT RED AND SORE. PT CLAIMS THEY FELT NO PAIN OR DISCOMFORT DURING MRI. THE RED, QUESTIONABLE BURN WAS REVIEWED BY PHYSICIAN'S OFFICE. PT WAS NOT TREATED. THE RED AREA WAS GRADUALLY GOING AWAY. THE PT WAS SCANNED USING MAGNET WITH THE QUAD HEAD COIL. MARK STARTED NEAR THE CENTER OF THE NECK AT THE SHOULDERS EXTENDING APPROX 6 INCHES TO THE RIGHT SHOULDER AND APPROX 2 INCHES WIDE. TECHNICAL EVALUATION/RESULTS: CALIBRATIONS WERE PERFORMED ON THE DATA ACQUISITION UNIT, RF AMPLIFIER, AND GRADIENT SYSTEM. ALL CALIBRATIONS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE HEAD COIL WAS DISASSEMBLED AND INSPECTED, NO PHYSICAL DAMAGE FOUND TO HARDWARE, ELECTRONICS OR CABLING. THE HEAD COIL IS A RECEIVE COIL AND THEREFORE IS NOT TRANSMITTING ANY RF RADIATION. THE HEAD COIL HAS NO KNOWN PROBLEMS IN THE PAST OR SINCE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYROSCAN ACS-NT HEAD COIL LNH PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other