BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO III-SV

    MDR report key: 2467713 · Received February 2, 2012

    Report

    Report Number
    3003807210-2011-00002
    Event Type
    Other
    Date Received
    February 2, 2012
    Date of Event
    October 17, 2011
    Report Date
    February 1, 2012
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K083137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT: ROOT CAUSE: THE FACT THAT EVEN THOUGH MR UNCONDITIONAL EQUIPMENT WAS MOVED OUTSIDE THE 50 GAUSS LINE FLOOR MARKINGS PRIOR TO MOVING THE MAGNET INTO THE AR AND WAS STILL DRAWN INTO THE MAGNET UPON MOVING THE MAGNET THROUGH THE SLIDING DOORS, INDICATES AN ERROR WITH IMRIS SYS DRAWING/PLANNING GUIDELINES. THE FACT THAT EMPLOYEE TRAINING RECORDS WERE INCOMPLETE AT THE TIME OF THE OCCURRENCE AND THERE WAS A LACK OF COMMUNICATION BETWEEN MEMBERS OF THE GROUP AS TO WHEN THE MAGNET SHOULD HAVE BEEN MOVED INDICATES USER ERROR. NEW FLOOR GAUSS LINE MARKINGS WERE DEVELOPED TO INCLUDE GAUSS LINE EXPOSURE DURING MAGNET MOVEMENT. REVISED THE INTRA-OPERATIVE USER MANUALS TO ACCURATELY DESCRIBE THE MOVING MAGNETIC FIELD AND IT'S FLOOR MARKINGS. UPDATED MANUALS ARE BEING SHIPPED TO ALL OF OUR CUSTOMERS WITH A COVER LETTER HIGHLIGHTING THE IMPORTANCE OF THE CHANGES REGARDING THE MOVING MAGNETIC FIELD. IT WAS DETERMINED THAT CHECKING THE GAUSS LINES IN THE FIELD AFTER COMMISSIONING IS NOT NECESSARY. LINES AS PUBLISHED IN OUR SITING GUIDES AND DRAWINGS ARE ACCURATE. THUS THERE IS NO VALUE ADDED BY MEASURING THE MAGNETIC FIELDS AFTER COMMISSIONING. AN ANNUAL TRAINING PROGRAM HAS BEEN IMPLEMENTED FOR IMRIS EMPLOYEES WHO WORK WITH THE MAGNET AT CUSTOMER SITES HAS BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    A SURGICAL HEADLIGHT WAS DRAWN INTO THE MAGNET WHILE THE MAGNET WAS BEING MOVED FROM THE DR TO THE AR TO COMPLETE COIL IMAGE TESTING FOLLOWING MAGNET SHIMMING. THREE IMRIS PERSONNEL WERE AT A CUSTOMER SITE TO RE-HIM THE MAGNET AND COMPLETE IMAGE TESTING (USING IMRIS COILS IN THE OPERATING ROOM AND AR) IN REGARDS TO IMAGE DISTORTION ISSUES THAT HAD BEEN RAISED BY THE CUSTOMER. SHIMMING WAS COMPLETED IN THE DR AND THE OPERATING ROOM AND THE MAGNET WAS RETURNED TO THE DR. PRIOR TO MOVING THE MAGNET INTO THE AR (OPENING THE AR SLIDING DOORS), ONE PERSON WENT INTO THE AR TO ENSURE IT WAS MR SAFE BY MOVING SEVERAL PIECES OF EQUIPMENT AWAY FROM THE 5 GAUSS LINE AND THEN RETURNED TO THE DR TO ROTATE THE MAGNET. DUE TO USER ERROR A SURGICAL HEADLIGHT NEAR THE MAGNET SLIDING DOOR WAS NOT MOVED PRIOR TO OPENING THE SLIDING DOORS FROM THE CONTROL ROOM, AND THE HEADLIGHT WAS DRAWN INTO THE MAGNET. NO INJURIES WERE REPORTED. IMRIS REPAIRED AND REPLACED THE DAMAGED SCANNER EQUIPMENT WITHIN TWO DAYS FOLLOWING THE OCCURRENCE TO RETURN THE SYS TO OPERATIONAL STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO III-SV MAGNETIC RESONANCE IMAGING SYSTEM LNH IMRIS, INC. 105828-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other NO