BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACHIEVA 1.5T NOVA

    MDR report key: 1252503 · Received November 20, 2008

    Report

    Report Number
    1217116-2008-00085
    Event Type
    Other
    Date Received
    November 20, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 10, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MFR TO SUBMIT THIS INCIDENT THAT OCCURRED IN OTHER COUNTRY. REPORTED PROBLEM: THE PT HAD AN MR EXAM. THE PT WAS CANNED WITH THE SENSE NEURO VASCULAR COIL. PADS WERE USED TO KEEP SUFFICIENT DISTANCE BETWEEN THE COIL CABLE AND THE PT. AFTER THE EXAMINATION, TWO SECOND DEGREE BURNS (BLISTERS) APPEARED ON THE RIGHT FOREARM . THE TWO 2ND DEGREE BURNS WERE 1.5 CM IN DIAMETER ON THE RIGHT FOREARM. THE BURNS WERE TREATED WITH TOPICAL OINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T NOVA LNH (SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING) LNH PHILIPS MEDICAL SYSTEMS 781196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other