BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMRIS IMRI 3T SKYRA SYSTEM

    MDR report key: 13516141 · Received February 11, 2022

    Report

    Report Number
    3010326005-2017-00002
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    April 4, 2017
    Report Date
    April 4, 2017
    Manufacturer
    IMRIS - DEERFIELD IMAGING, INC
    Product Code
    LNH
    UDI-DI
    00857534006035
    PMA / PMN Number
    K133692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS A KNOWN RISK THAT THE INTRODUCTION OF FERROUS OBJECTS INTO THE MR SUITE CAN CAUSE DAMAGE OR INJURY IF THEY ARE DRAWN TOWARDS THE MAGNET. ALL SUITES ARE EQUIPPED WITH SAFETY LABELS INFORMING USERS AND VISITORS OF THE HAZARDS INTRINSIC TO THE MR ENVIRONMENT. THE UNDERLYING CAUSE OF THE INCIDENT WAS USER ERROR. THE SERVICE TECHNICIAN FAILED TO VERIFY THAT THE MAGNET WAS DEPLOYED AND THAT THE SERVER ON THE EQUIPMENT RACK WAS LOCATED IN AN MR UNSAFE ZONE. THIS MDR IS BEING SUBMITTED OUTSIDE OF THE REQUIRED TIMEFRAME AS PART OF REMEDIAL ACTION INITIATED BY THE MANUFACTURER, IN RESPONSE TO INTERNALLY IDENTIFIED ISSUES REGARDING FAILED ELECTRONIC SUBMISSIONS THROUGH WEBTRADER.

    Description of Event or Problem · 0

    ON (B)(6) 2017, A SIEMENS SERVICE TECHNICIAN WAS WORKING ON A SOFTWARE UPGRADE IN THE EQUIPMENT ROOM POSITIONED ADJACENT TO THE MAGNET IN THE DIAGNOSTIC ROOM. AS THE TECHNICIAN WAS ATTEMPTING TO REMOVE AND REPLACE A COMPUTER SERVER FROM THE EQUIPMENT RACK, THE SERVER ATTRACTED TO THE MAGNET. THE TECHNICIAN'S LEFT HAND WAS CAUGHT BETWEEN THE SERVER AND THE MAGNET. THE TECHNICIAN WAS ABLE TO EXTRICATE HIS LEFT HAND FROM BETWEEN THE MAGNET AND THE EQUIPMENT, AND DAMAGE TO THE TECHNICIAN'S MIDDLE FINGER OCCURRED DURING THIS PROCESS. THE TECHNICIAN WAS TREATED IN THE EMERGENCY ROOM ONSITE. THE MAGNET WAS RAMPED DOWN TO RETRIEVE THE SERVER FROM THE SIDE OF THE MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91339 IMRIS IMRI 3T SKYRA SYSTEM MRI MAGNET LNH IMRIS - DEERFIELD IMAGING, INC 3T SKYRA 00857534006035

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Hospitalization