BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 1080710 · Received July 9, 2008

    Report

    Report Number
    1217116-2008-00045
    Event Type
    Other
    Date Received
    July 9, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 20, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MR MFR, OF AN EVENT THAT OCCURRED IN ANOTHER COUNTRY. THE PT WAS SCANNED WITH THE FEET FIRST INTO THE MAGNET. THE PT WAS AN AUTISTIC PERSON AND WAS ON GENERAL ANESTHETIC DURING THE EXAMINATION. THEREFORE, ECG-LEADS, OXYGEN SATURATION, AND A TUBE FOR ANESTHESIA WERE ALSO CONNECTED TO THE PT. AFTER THE SCAN A SECOND DEGREE BURN WITH BLISTER (5CM) APPEARED ON THE RIGHT ARM, BETWEEN THE WRIST AND ELBOW WHERE THE ARM WAS TOUCHING THE CABLE OF THE RF-COIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T NOVA LNH ( MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other