BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE 1.5T SIGNA HDX MR SYSTEM

    MDR report key: 18321009 · Received December 13, 2023

    Report

    Report Number
    2183553-2023-00010
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 18, 2023
    Report Date
    February 6, 2024
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    H3: GE HEALTHCARE (GEHC) INVESTIGATION HAS BEEN COMPLETED. A GEHC FIELD ENGINEER (FE) WAS REPLACING THE ICN ON AN MR SYSTEM AND WHILE PERFORMING THE SERVICE, THE FE WALKED THROUGH THE MAGNET ROOM WITH THE ICN WHICH WAS ATTRACTED TOWARD THE MR SYSTEM. THE FE PINKY FINGER WAS PINCHED BETWEEN THE ICN AND THE REAR COVER OF THE MR SYSTEM WHICH RESULTED IN A FRACTURE. THE ICN IS A FERROUS COMPONENT OF THE MR SYSTEM THAT IS INSTALLED IN THE EQUIPMENT ROOM WHERE THERE IS NO MAGNETIC FIELD. THE ROOT CAUSE OF THIS INCIDENT WAS USE ERROR AS THE MR MAGNET SAFETY REQUIREMENTS WERE NOT FOLLOWED. SERVICE PROCEDURE DOCUMENTS PROVIDE STEPS TO SAFELY REPLACE THE ICN IN THE EQUIPMENT ROOM. THE FE PERFORMING THE PROCEDURE HAS HAD THE APPROPRIATE TRAINING. GEHC MR SERVICE SAFETY DEFINE THE RISKS ASSOCIATED WITH ENTERING THE SCAN ROOM WITH FERROUS MATERIALS. NO FURTHER ACTIONS ARE PLANNED BY GEHC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE SERVICING AN MR SYSTEM, A GE HEALTHCARE FIELD ENGINEER (FE) WALKED THROUGH THE MAGNET ROOM WITH AN IMAGE COMPUTE NODE (ICN) WHICH WAS ATTRACTED TO THE MAGNET. THE FE'S PINKY FINGER WAS PINCHED BETWEEN THE ICN AND THE REAR COVER OF THE MR SYSTEM WHICH RESULTED IN A FRACTURED FINGER. FIRST AID AND FIXATION TREATMENT WAS PROVIDED FOR THE FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680477 GE 1.5T SIGNA HDX MR SYSTEM NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Other