BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO II-S (OR)

    MDR report key: 2490130 · Received March 16, 2011

    Report

    Report Number
    3003807210-2010-00002
    Event Type
    Other
    Date Received
    March 16, 2011
    Date of Event
    May 27, 2010
    Report Date
    June 25, 2010
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K050132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A FERROMAGNETIC OBJECT WAS PULLED INTO THE BORE OF THE MAGNET. THE CUSTOMER HAD COMPLETED A SCAN AND WAS PREPARING THE OPERATING ROOM SUITE TO RESUME WITH SURGERY. THE CUSTOMER ROLLED A LAMP POLE BEHIND THE HEAD OF THE OPERATING ROOM TABLE BEFORE THE MAGNET HAD BEEN FULLY RETURNED TO THE MAGNET BAY. THE LAMP WAS PULLED INTO THE BORE OF THE MAGNET. THE MAGNET AND LAMP WERE WELL AWAY FROM THE PT AT THE TIME OF THE INCIDENT AND THERE WERE NO INJURIES TO ANY PERSONNEL OR THE PT. THE CUSTOMER REMOVED THE LAMP FROM THE MAGNET; THERE WAS SOME COSMETIC DAMAGE TO THE FOAM PORTION OF THE COLLISION DETECTION RING AS WELL AS TO THE REAR BORE LINER. NO FURTHER CORRECTIVE ACTION IS REQUIRED AS THERE IS A KNOWN RISK THAT THE INTRODUCTION OF FERROUS OBJECTS INTO THE MR SUITE CAN CAUSE DAMAGE OR INJURY IF THEY ARE PULLED TOWARD THE MAGNET. ALL SUITES ARE EQUIPPED WITH SAFETY LABELS INFORMING ALL VISITORS AND USERS OF THE HAZARDS INTRINSIC TO THE MR ENVIRONMENT WHICH MUST BE RESPECTED. AS PART OF THE DEVICE TRANSFER TO THE CUSTOMER, TRAINING IS CONDUCTED PRIOR TO SYSTEM TURNOVER. ALSO, THE USER MANUAL CONTAINS INFO ABOUT THE HAZARDS IN ALLOWING FERROMAGNETIC ITEMS TO BE BROUGHT INTO THE MAGNET AND BECOME POTENTIALLY DANGEROUS PROJECTILES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-S (OR) MAGNETIC RESONANCE IMAGING SYSTEM LNH IMRIS, INC. 103070-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening NO