BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMRIS NEURO II-SE

    MDR report key: 2858094 · Received December 3, 2012

    Report

    Report Number
    3003807210-2012-00006
    Event Type
    Other
    Date Received
    December 3, 2012
    Date of Event
    October 10, 2012
    Report Date
    December 3, 2012
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K071099
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INCIDENT OCCURRED IN AN IMRIS NEURO II-SE SUITE ON THE DIAGNOSTIC TABLE PROVIDED BY SIEMENS. THE DIAGNOSTIC TABLE IS ATTACHED TO THE SIEMENS ESPREE MAGNET ((B)(4)) AND IS USED UNMODIFIED IN THE IMRIS SYSTEM. WHEN PUTTING A MALE MENINGITIS PATIENT ON THE TABLE WITH A NURSE ON ONE SIDE AND A FAMILY MEMBER AT THE FOOT AND THE MR TECHNOLOGIST ON THE SIDE OF THE TABLE WITH THE STRETCHER. THE PATIENT WAS TRANSFERRED FROM THE STRETCHER ONTO THE TABLE AND AS THEY WERE MOVING THE STRETCHER AWAY FROM THE TABLE, THE PATIENT STARTED TO ROLL OFF. THE TECHNOLOGIST JAMMED THE STRETCHER BACK AGAINST THE TABLE TO STOP THE PATIENT FROM ROLLING OFF AND THEY WERE ABLE TO STABILIZE THE PATIENT. SIEMENS INVESTIGATED THE ISSUE AND DETERMINED THAT THE TABLE WAS OPERATING PER SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMRIS NEURO II-SE IMRIS NEURO II-SE INTRA-OPERATIVE MR SYS LNH IMRIS, INC. NEURO II-SE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other