BEUDAMED
    FDA Adverse Event Other Summary report: N

    *

    MDR report key: 1084993 · Received April 23, 2008

    Report

    Report Number
    3003768277-2008-00001
    Event Type
    Other
    Date Received
    April 23, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    LNH
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: THE PT BURN WAS 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 ISOLATION MATERIAL BETWEEN THE SKINS. THESE KINDS OF INCIDENTS CAN BE PREVENTED BY SEPARATING BARE SKIN PARTS OF THE PT BY WEDGES OR CUSHIONS. THE INSTRUCTIONS FOR USE ALREADY CONTAINS EXTENSIVE WARNINGS. NOTE: THE INDICATED IMPORTER HAS REC'D FDA EXEMPTION NUMBER TO SUBMIT ONE FDA FORM 3500A TO SATISFY BOTH THE IMPORTER AND MFR 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 Unknown N
    2