BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T

    MDR report key: 1372982 · Received April 21, 2009

    Report

    Report Number
    3003768277-2009-00032
    Event Type
    Other
    Date Received
    April 21, 2009
    Date of Event
    March 3, 2009
    Report Date
    March 6, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K001786
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (CONCLUSIONS) - THE CONCLUSION IS THAT THE BURNS WERE CAUSED BY SKIN-SKIN CONTACT. SKIN-SKIN BURNS ARE A KNOWN CAUSE FOR RF BURNS DURING AN MRI SCAN. THE BEST WAY TO PREVENT SKIN-SKIN RF BURNS IS TO CREATE ENOUGH ISOLATION BETWEEN THE TWO SKIN SURFACES EITHER BY DISTANCE OR BY AN ISOLATING MATERIAL BETWEEN THE SKINS. ALSO, IT WAS OBSERVED THAT HIGH SAR LEVELS WERE USED BY THE OPERATOR. THESE KINDS OF INCIDENTS CAN BE PREVENTED BY SEPARATING BARE SKIN PARTS OF THE PT BY WEDGES OR CUSHIONS. THEREFORE, AN ACCESSORY KIT IS PART OF EVERY MR SYSTEM DELIVERY CONTAINING SEVERAL SPACERS AND CUSHIONS. THE INSTRUCTIONS FOR USE CONTAINS WARNINGS ON THESE MATTERS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MR MANUFACTURER IN (B)(4) TO SUBMIT THIS INCIDENT THAT OCCURRED IN (B)(6). PROBLEM: THE PT HAD A MR PROCEDURE. THE PT WAS SCANNED WITH THE SYNERGY BODY COIL (SBC) POSITIONED WITH THE FEET FIRST INTO THE MAGNET. THE SBC WAS ROTATED 90 DEGREES AND PLACED OVER THE MID THIGHS. IMMEDIATELY AFTER THE SCAN, MINOR SECOND DEGREE BURNS APPEARED AT THE INSIDE OF BOTH LEGS IN THE AREA OF THE CALVES. IT WAS NOT UNTIL WEEKS LATER IT WAS DISCOVERED THAT THE INJURY WAS ACTUALLY A SEVERE SECOND DEGREE BURN WITH BLISTERS AROUND 2.5 CM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 7811106 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other