BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO II-SE, OR-DR CONFIGURATION

    MDR report key: 2490132 · Received March 16, 2011

    Report

    Report Number
    3003807210-2009-00001
    Event Type
    Other
    Date Received
    March 16, 2011
    Date of Event
    September 4, 2009
    Report Date
    September 29, 2009
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K050132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CONTRACTOR WORKING AT THE SACRED HEART HOSP SITE LOCATED IN (B)(4), REQUESTED ADMITTANCE TO THE IMRIS OR/DR SUITE. WHILE THERE THE CONTRACTOR BROUGHT A CHAIR FROM THE CONTROL ROOM INTO THE DIAGNOSTIC ROOM WHERE THE MAGNET WAS LOCATED. THE CHAIR BROUGHT IN WAS MR UNSAFE AND WAS PULLED INTO THE MAGNET. THE SUITE WAS NOT IN USE AT THE TIME AND THERE WERE NO INJURIES TO ANY PERSONNEL. UNDER THE DIRECTION OF THE HOSP MR ADMINISTRATION, THE CHAIR WAS LATER REMOVED THROUGH USE OF NYLON STRAPS WITHOUT RAMPING DOWN THE MAGNET. THE MAGNET WAS ALLOWED TO SETTLE OVER THE WEEKEND. ON TUESDAY MORNING, HOSP PERSONNEL RAN THE STANDARD QA TESTS AND THE SYSTEM PASSED. THE SYSTEM IS NOW UP AND RUNNING. PHYSICAL DAMAGE TO THE MAGNET COVERS WAS MINOR WITH A FEW SCRATCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-SE, OR-DR CONFIGURATION MAGNETIC RES IMAGING SYSTEM LNH IMRIS, INC. 105000-001 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Life Threatening| O NO