BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO III-SV

    MDR report key: 2677651 · Received July 26, 2012

    Report

    Report Number
    3003807210-2012-00004
    Event Type
    Other
    Date Received
    July 26, 2012
    Date of Event
    April 25, 2012
    Report Date
    July 26, 2012
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE INVESTIGATION DETERMINED THAT THE INCIDENT WAS CAUSED BY FAILURE TO FOLLOW OPERATING INSTRUCTIONS. THE OPERATING ROOM TABLE MUST BE LOCKED AND POSITIONED AT ZERO DEGREES RELATIVE TO THE MAGNET. THIS WAS NOT DONE. ALSO, IMRIS DETERMINED THAT THE OPERATING ROOM TABLE USER MANUAL AND LABELS DO NOT CLEARLY SPECIFY THAT THE OPERATING ROOM TABLES MAY MOVE IN THE PRESENCE OF THE MAGNET IF THE OPERATING ROOM TABLE IS NOT LOCKED OR NOT IN THE ZERO DEGREES POSITION RELATIVE TO THE TABLE. CAPA (B)(4) HAS BEEN ISSUED TO TRACK THE CORRECTIVE ACTION PLANS.

    Description of Event or Problem · 1

    IMRIS WAS NOTIFIED THAT DURING MOVEMENT OF THE MAGNET INTO THE IMAGING POSITION IN THE OPERATING ROOM FOR SHIM TEST BY AN IMRIS TECH, PART OF THE ORT100 TABLE WAS DRAWN TOWARDS THE MAGNET (ORT100 TABLE FOOT END SECTION). THE IMRIS TECH REPORTED THAT THE ORT100 TABLE BRAKE PEDAL WAS LOCKED, BUT HAD GIVEN WAY WHEN THE BACK SECTION WAS BEING REMOVED. THE IMRIS TECH ALSO REPORTED THAT THE ORT100 WAS POSITIONED INCORRECTLY FOR IMAGING (90 DEGREES) AT THIS TIME, RATHER THAN THE REQUIRED 0 DEGREES. THERE WERE NO INJURIES REPORTED AT THE TIME OF THE OCCURRENCE. EQUIPMENT DAMAGE WAS SUSTAINED TO THE MAGNET COVERS. THE TECHNICIAN WITH SOME ASSISTANCE WAS ABLE TO ROTATE THE TABLE AND PRIED IT AWAY FROM THE MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO III-SV NEURO III-SV INTRA-OPERATIVE MRI SYSTEM LNH IMRIS, INC. 105117-004 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other