BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURO III-SV 3T VERIO MAGNET

    MDR report key: 4336872 · Received December 17, 2014

    Report

    Report Number
    3003807210-2014-00004
    Event Type
    Injury
    Date Received
    December 17, 2014
    Date of Event
    December 2, 2014
    Report Date
    December 17, 2014
    Manufacturer
    IMRIS, INC.
    Product Code
    LNH
    PMA / PMN Number
    K083137
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO MALFUNCTION OF THE SYSTEM. USER ERROR WAS THE ROOT CAUSE OF THE EVENT. THE FIELD SERVICE TECHNICIAN NEGLECTED TO MOVE THE MAGNET OUT OF THE OR SUITE PRIOR TO BRINGING IN THE IMAGING EQUIPMENT. THE TECHNICIAN WAS AWARE THAT THE EQUIPMENT WAS MR-UNSAFE AND WAS PREVIOUSLY TRAINED ON MR SAFETY. THE SYSTEM WAS QUENCHED THE FOLLOWING DAY IN ORDER TO REMOVE THE IMAGER FROM THE BORE OF THE MAGNET. THE DAMAGED COMPONENTS AND COVER ARE TO BE REPLACED AND ARE ON ORDER. THE SYSTEM WAS INSPECTED BEFORE RAMPING THE MAGNET BACK UP.

    Description of Event or Problem · 1

    ON (B)(6) 2014 AT (B)(6), A SIEMENS FIELD SERVICE TECHNICIAN INADVERTENTLY BROUGHT IMAGING EQUIPMENT INTO THE OPERATING ROOM SUITE NEAR THE END OF THE DEPLOYED MAGNET. THE IMAGER WAS DRAWN INTO THE BORE OF THE MAGNET, RESULTING IN A BROKEN SHOULDER AND FRACTURED RIBS TO THE TECHNICIAN. THERE WAS NO MALFUNCTION OF THE SYSTEM. THE EVENT WAS CAUSED BY USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826869 NEURO III-SV 3T VERIO MAGNET MRI MAGNET LNH IMRIS, INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Life Threatening