BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO III-SV INTRAOPERATIVE MRI SYSTEM

    MDR report key: 3181660 · Received June 14, 2013

    Report

    Report Number
    3003807210-2013-00001
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    IMRIS INC.
    Product Code
    LNH
    PMA / PMN Number
    K083137
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMRIS CUSTOMER SUPPORT SPECIALIST TESTED THE MAGNET MOVER BACK AND FORTH INTO OPERATING ROOM AND COULD NOT DUPLICATE THE FAILURE. IMRIS CUSTOMER SUPPORT AND DEVELOPMENT SPECIALIST REMOTELY COLLECTED THE LOGS FROM THE MATRIX COMPUTER FOR FURTHER ROOT CAUSE ANALYSIS. IMRIS DETERMINED THAT THE ERRONEOUS REVERSE MOVEMENT OCCURRED ON (B)(6) 2013, AT THE TIME 12:00:23.938 IN OPERATING ROOM 1. THE FWD BUTTON WAS PUSHED, BUT SERVO COUNTS WERE SHOWN TO BE DECREASING, WHICH DEMONSTRATES THAT THE SERVO WAS MOVING THE MAGNET IN THE REVERSE DIRECTION. THIS MATCHES THE RACE CONDITION SIGNATURE THAT WAS OBSERVED IN COMPLAINT CASE #(B)(4) IN WHICH A MEDICAL DEVICE REPORT WAS FILED AND APPEARS TO BE THE SAME ROOT CAUSE MANIFESTING AS THE INCORRECT SERVO INDEX. ALL LOG ENTRIES WERE CHECKED FOR ERRONEOUS FORWARD MOVEMENT AND ERRONEOUS REVERSE MOVEMENTS (29,269 LOG ENTRIES). NO OTHER ERRONEOUS MOVEMENTS WERE OBSERVED. 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 REVERSE MOTION WHEN THE FORWARD BUTTON WAS PRESSED BY THE OPERATOR . ON (B)(4) 2013, THE CUSTOMER SITE WAS UPGRADED WITH THE MMC 2.1 SOFTWARE RELEASE TO RESOLVE ALL THE IDENTIFIED CAUSES OF ERRONEOUS MOVEMENT. (REF MDR 3003807210-2012-00002). ALL OTHER SIMILAR SITES WILL ALSO BE UPGRADED TO MMC 2.1 THAT HAVE NOT BEEN UPGRADED ALREADY.

    Description of Event or Problem · 1

    THE MAGNET MOVER MOVED BACKWARD AT THE PT SAFETY CHECK POINT (PSCP) WHEN PRESSING THE FORWARD BUTTON. THEN IT STOPPED MOVING. OPERATING ROOM PERSONNEL CRANKED IT HOME AND RESET IT. NO PT WAS INVOLVED WITH THE VENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271099 NEURO III-SV INTRAOPERATIVE MRI SYSTEM MAGNETIC RESONANCE IMAGING SYSTEM LNH IMRIS INC. NEURO III-SV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other