BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1286924 · Received January 5, 2009

    Report

    Report Number
    3003768277-2009-00001
    Event Type
    Other
    Date Received
    January 5, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    PMA / PMN Number
    k001796
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCLUSION IS THAT THESE BURNS WERE CAUSED BY SKIN-TO-SKIN CONTACT BETWEEN THE LEFT MIDDLE FINGER AND LEFT THIGH. SKIN-TO-SKIN BURNS ARE A WELL KNOWN CAUSE FOR RF BURNS DURING AN MRI SCAN. IF THE CONTACTING SURFACE AREA IS EXTREMELY SMALL AND THUS THE CURRENT DENSITY IS HIGH, THE PT'S TISSUE CAN BE HEATED UP ENOUGH TO CREATE AN RF BURN. THE BEST WAY TO PREVENT SKIN-TO-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 HIGH SAR LEVELS WERE USED RESULTING IN WARNING MESSAGES FOR THE OPERATOR. THESE MESSAGES WERE ACCEPTED BY THE OPERATOR AND THE SCANS WITH HIGH SAR WERE CONTINUED ON THE PT. THE INSTRUCTIONS FOR USE ALREADY CONTAIN EXTENSIVE WARNINGS TO PREVENT PT HEATING. NOTE THE INDICATED IMPORTER HAS REC'D FDA EXEMPTION #, TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER (803.42) AND MFR (803.52) FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * LNH PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. * *

    Patients

    Seq Age Sex Outcome Treatment
    1