BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERA ACHIEVA 1.5T NOVA DUAL

    MDR report key: 1012286 · Received March 6, 2008

    Report

    Report Number
    1217116-2008-00017
    Event Type
    Other
    Date Received
    March 6, 2008
    Date of Event
    December 24, 2007
    Report Date
    February 5, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LNH
    PMA / PMN Number
    K001987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (EVAL - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. (EVAL RESULTS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA. (CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED UPON NOTIFICATION FROM OUR MR MANUFACTURER, OF AN EVENT THAT OCCURRED IN ANOTHER COUNTRY. THE PT WAS HAVING A MRI SCAN. PATIENT WAS SCANNED WITH THEIR FEET FIRST INTO THE MAGNET AND LYING ON THEIR BACK. THE MR COIL WAS POSITIONED FOR A PELVIS EXAMINATION WITH ONE ELEMENT ON TOP AND THE OTHER ELEMENT UNDER THE PT. IMMEDIATELY AFTER THE EXAMINATION A SECOND DEGREE BURN, 5 CM IN DIAMETER, WAS NOTICED AT THE UPPER LEFT SIDE OF THE THIGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERA ACHIEVA 1.5T NOVA DUAL LNH (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) LNH PHILIPS MEDICAL SYSTEMS 781108 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other