BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO II-SE (OR-DR)

    MDR report key: 2490103 · Received March 16, 2011

    Report

    Report Number
    3003807210-2010-00001
    Event Type
    Other
    Date Received
    March 16, 2011
    Date of Event
    May 7, 2010
    Report Date
    June 3, 2010
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K061916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CONTRACTOR FOR THE USER FACILITY WAS ALLOWED INTO THE DIAGNOSTIC ROOM OF THE MR SUITE BY HOSP STAFF, WITH A METAL FOLDING CHAIR. THE CHAIR FLEW INTO THE FACE OF THE MAGNET HITTING THE CONTROL PANEL OF THE DIAGNOSTIC TABLE. THIS ACTIVATED THE DIAGNOSTIC TABLE TO GO INTO THE MAGNET, TEARING THE CABLES FOR THE RF COIL CONNECTORS. THE MR SUITE WAS NOT IN CLINICAL USE AT THE TIME OF THE INCIDENT, AND THERE WERE NO REPORTED INJURIES TO ANY PERSONNEL. HOSP STAFF ARE MADE AWARE THROUGH TRAINING PRIOR TO SYSTEM TURNOVER, OF THE HAZARD IN ALLOWING FERROMAGNETIC ITEMS TO BE BROUGHT INTO THE MAGNETIC FIELD WHICH CAN THEN BECOME ATTRACTED TO THE MAGNET, AND BECOME POTENTIALLY DANGEROUS PROJECTILES. THE OPERATOR MANUALS ALSO INCLUDE WARNINGS WITH REGARDS TO FERROUS OBJECTS NOT BEING ALLOWED INTO THE MAGNET ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-SE (OR-DR) MAGNETIC RESONANCE IMAGING SYSTEM LNH IMRIS, INC. 105087-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening NO