BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACHIEVA 1.5T

    MDR report key: 1275223 · Received December 19, 2008

    Report

    Report Number
    1217116-2008-00091
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    July 2, 2008
    Report Date
    August 5, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA
    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 MR MFR TO SUBMIT THIS INCIDENT THAT OCCURRED IN ANOTHER COUNTRY. PROBLEM: THE PT HAD A MR PROCEDURE. THE PT WAS SCANNED WITH THE 8 CHANNEL SENSE HEAD COIL WITH THE CABLE ON THE RIGHT SIDE OF THE PT'S HUMERUS. PT WAS DRESSED WITH LONG SLEEVE SHIRT WITH A SHEET PLACED BETWEEN THE CABLE AND ARM. AFTER THE EXAMINATION, A SECOND DEGREE RF BURN APPEARED ON THE LOWER THIRD OF THE RIGHT HUMERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHIEVA 1.5T LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS NORTH AMERICA 781196 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other