BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA 1.5T MASTER/NOVA

    MDR report key: 2015790 · Received March 9, 2011

    Report

    Report Number
    3003768277-2011-00266
    Event Type
    Other
    Date Received
    March 9, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    LNH
    PMA / PMN Number
    K001796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE INCIDENT REPORTED IS MOST LIKELY CAUSED BY SKIN-SKIN CONTACT BETWEEN THE INNER THIGHS. THE FACT THAT SEVERAL SANS WITH HIGH SARS VALUES WERE USED MAY HAVE CONTRIBUTED AS WELL. 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. THEREFORE AN ACCESSORY SET IS PART OF EVERY MR SYSTEM DELIVERY CONTAINING SEVERAL SPACERS AND CUSHIONS. THE INSTRUCTIONS FOR USE CONTAIN EXTENSIVE WARNINGS AND INSTRUCTIONS FOR PT POSITIONING.

    Description of Event or Problem · 1

    THE PT WAS SCANNED FOR A PELVIS EXAMINATION WITH THE QBC POSITIONED HEAD FIRST, SUPINE. ALSO THE SPINE COIL WAS POSITIONED FOR A LUMBAR STUDY, HOWEVER WAS NOT IN USE AND NOT CONNECTED AT THE TIME OF THE BURN. IMMEDIATELY AFTER THE EXAMINATION 2 SECOND DEGREE BURNS OVER 1CM IN DIAMETER ON BOTH THE INNER THIGHS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA 1.5T MASTER/NOVA LNH PHILIPS HEALTHCARE 781106

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other