BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T NOVA

    MDR report key: 1012284 · Received March 7, 2008

    Report

    Report Number
    1217116-2008-00016
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    October 18, 2007
    Report Date
    October 29, 2007
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    4254877199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BURN WAS CAUSED BY SKIN-SKIN CONTACT. SKIN-SKIN BURNS ARE A WELL 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. IN THIS CASE THE BURN AREA WAS RATHER LARGE AND IT WAS MENTIONED THAT THE PT WAS SWEATING BETWEEN THE LEGS. ALSO, IT WAS OBSERVED THAT AT LEAST ONE SCAN HAD A HIGH SAR VALUE. THE INSTRUCTIONS FOR USE, ALREADY CONTAINS WARNINGS. I.E., "PATIENTS CLOTHING MUST NOT ALLOW SKIN TO SKIN CONTACT. CARE MUST BE TAKEN TO AVOID CURRENT LOOPS: PLACE INSULATING MATERIAL (E.G. FOAM) BETWEEN AND OUTSIDE THE PT'S LEGS TO PREVENT LEG-TO-LEG CONTACT OR LEG-TO-ARM/HAND CONTACT. THERE IS A RISK OF BURNING DUE TO GENERATION OF HIGH CURRENT LOOPS IF THE LEGS/ARMS ARE ALLOWED TO TOUCH."

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MFR IN (B) (4) OF AN EVENT THAT OCCURRED IN (B) (6). THE PT HAD A MRI PROCEDURE PERFORMED ON THEM. THE PT REC'D TWO SECOND DEGREES BURNS APPROX 10 CM BY 15 CM THAT WERE LOCATED ON THE INNER THIGHS. THE BURNS REQUIRED MEDICAL TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T NOVA LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781106 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other