BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 23223444 · Received October 6, 2025

    Report

    Report Number
    3010949642-2025-00006
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    June 6, 2025
    Report Date
    November 21, 2025
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K192426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1, 2; B4; G1, 3, 6; H2, 3, 6. H3: GE HEALTHCARE (GEHC) HAS COMPLETED ITS INVESTIGATION. AN MR TECHNOLOGIST INTRODUCED A NON-FERROUS CHAIR WITH AN ATTACHED FERROUS IV POLE INTO THE MR SCAN ROOM. THE FERROUS OBJECT BECAME ATTRACTED TO THE MAGNETIC FIELD AND STRUCK A SECOND TECHNOLOGIST WHO WAS ALSO PRESENT IN THE SCAN ROOM RESULTING IN INJURY. THE SITE CONFIRMED THAT MR SAFETY SIGNAGE WAS APPROPRIATELY DISPLAYED AND THAT THE INVOLVED MR TECHNOLOGIST HAD RECEIVED TRAINING IN MR SAFETY PROTOCOLS. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE INATTENTIVE PERSONNEL WHICH IS A USE ERROR. GEHC OPERATOR DOCUMENTATION OUTLINES THE RISKS AND SAFETY PRECAUTIONS ASSOCIATED WITH BRINGING FERROUS MATERIALS INTO THE SCAN ROOM WHILE THE MAGNET IS AT FIELD. NO FURTHER ACTION IS PLANNED BY GEHC.

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS TIANJIN - NO.266 JINGSAN ROAD, TIANJIN AIRPORT ECONOMIC AREA CHINA TIANJIN, 300308. A: NO ADDITIONAL PATIENT INFORMATION HAS BEEN PROVIDED. GE HEALTHCARE HAS REQUESTED PATIENT INFORMATION FROM INITIAL REPORTER. 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.

    Description of Event or Problem · 0

    A TECHNOLOGIST BROUGHT A NON-FERROUS CHAIR WITH AN ATTACHED FERROUS IV POLE INTO THE MR SCAN ROOM, RESULTING IN IT BECOMING ATTRACTED AND ATTACHED TO THE MAGNET. DURING THE INCIDENT, A SECOND TECHNOLOGIST ALSO IN THE MR SCAN ROOM WAS STRUCK BY THE OBJECT AND SUSTAINED A THUMB FRACTURE, WHICH WAS TREATED WITH A SPLINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342572 NA NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA VOYAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other