BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO II-SE

    MDR report key: 2536318 · Received March 30, 2012

    Report

    Report Number
    3003807210-2012-00002
    Event Type
    Other
    Date Received
    March 30, 2012
    Date of Event
    February 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K061916
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMRIS DETERMINED THAT THE ROOT CAUSE OF THE INCIDENT WAS THAT THE MOTOR SERVO USED TO CONTROL THE MAGNET WAS IN AN INCORRECT STATE, CAUSING FORWARD MOTION WHEN THE REVERSE BUTTON WAS PRESSED BY THE OPERATOR. IMRIS HAS ADDRESSED THE ISSUE THROUGH USE OF AN ENGINEERING CHANGE ORDER WHICH WAS USED TO VALIDATE AND IMPLEMENT A SOFTWARE UPGRADE TO CORRECT THE ERROR. A FIELD CHANGE ORDER IS IN PLACE FOR IMPLEMENTATION OF THE UPGRADE AT ALL SITES WITH THIS SYSTEM. THE UPGRADES WILL BE COMPLETED BY APRIL 13, 2012.

    Description of Event or Problem · 1

    THE FACILITY HAD A PT ON THE TABLE AND IMMOBILIZED BY SKULL CLAMP. THE MRI WAS BROUGHT INTO THE OPERATING ROOM UNTIL APPROXIMATELY 5CM IN FRONT OF THE PT'S HEAD. WHEN THE MAGNET WAS APPROXIMATELY 2CM AWAY FROM THE PT / SKULL CLAMP, IT WAS DETERMINED THAT THE SYSTEM NEEDED TO BE MOVED BACK IN ORDER TO MAKE SOME ADJUSTMENTS. THE REVERSE BUTTON WAS PUSHED, BUT THE SYSTEM MOVED FORWARD INSTEAD. REVIEW OF DATA LOGS FROM THE THREE USER FACILITIES WITH THE SAME SYSTEM REVEALED THAT A SIMILAR ERROR HAD TAKEN OCCURRED AT ONE FACILITY, HOWEVER, THIS INCIDENT WAS NOT REPORTED TO IMRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-SE MAGNETIC RESONANCE IMAGING SYSTEM LNH IMRIS, INC. 105119-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other