BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMRIS NEURO III-SV SYSTEM WITH 3T VERIO MAGNET

    MDR report key: 5088648 · Received September 18, 2015

    Report

    Report Number
    3003807210-2015-00001
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 17, 2015
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K083137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DUE TO USER ERROR ON THE PART OF MONTERIS SERVICE PERSONNEL HANDLING A MONTERIS CARBON DIOXIDE TANK IN THE PROXIMITY OF A DEPLOYED MAGNET. IMRIS DOES NOT SELL, IMPORT OR DISTRIBUTE MONTERIS PRODUCTS.

    Description of Event or Problem · 1

    THE MONTERIS SYSTEM INCLUDES TWO CARBON DIOXIDE (CO2) TANKS AND ASSOCIATED VALVE RACK TO COOL THE LASER. THE SYSTEM EQUIPMENT CABINET IS IN THE MAGNET BAY ROOM. A MONTERIS SERVICE TECHNICIAN WAS CHECKING FOR A POTENTIAL LEAK IN THE CO2 SYSTEM. HE DECIDED TO CHECK IF THE POSSIBLE LEAK WAS WITH THE CONNECTION ON THE NEW CO2 TANK AND BROUGHT AN EMPTY CO2 TANK BACK INTO THE OR SUITE TO TEST ITS CONNECTION. THE EMPTY CO2 TANK WAS DRAWN INTO THE MAGNET OF THE IMRIS NEURO III-SV SYSTEM. THE IMRIS MAGNET NEEDS TO MOVE FROM THE MAGNET BAY IN ORDER TO CHANGE THE CANNISTERS. THE TECHNICIAN FAILED TO MOVE THE MAGNET THIS TIME. PLEASE NOTE THAT IMRIS DOES NOT SELL, IMPORT, OR DISTRIBUTE ANY MONTERIS PRODUCTS. THE SERVICE TECHNICIAN SUSTAINED SOME MINOR SCRAPES ON THE PALMS OF HIS HANDS THAT DID NOT REQUIRE MEDICAL INTERVENTION. THE EVENT WAS CAUSED BY TECHNICIAN ERROR. THE MAGNET SUSTAINED DAMAGE TO SEVERAL OF ITS COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618126 IMRIS NEURO III-SV SYSTEM WITH 3T VERIO MAGNET MRI MAGNET LNH IMRIS, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening