BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 24020678 · Received January 9, 2026

    Report

    Report Number
    3010949642-2026-00001
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 3, 2025
    Report Date
    February 12, 2026
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2, 3, 6. H3: GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. A NURSE ENTERED THE MR SCAN ROOM WITH A PORTABLE OXYGEN TANK THAT WAS FERROMAGNETIC. THE FERROUS OBJECT BECAME ATTRACTED TO THE MAGNETIC FIELD AND WAS PULLED TOWARD THE MAGNET BORE. THE NURSE ATTEMPTED TO STOP THE OBJECT BUT WAS UNABLE TO DO SO AND SUSTAINED A FINGER INJURY. THE SITE CONFIRMED THAT MR SAFETY SIGNAGE WAS APPROPRIATELY DISPLAYED AND THAT THE INVOLVED NURSING TECHNICIAN HAD RECEIVED TRAINING IN MR SAFETY PROTOCOLS. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE USE ERROR (INATTENTIVE PERSONNEL). THE OPERATOR DOCUMENTATION OUTLINES THE RISKS AND SAFETY PRECAUTIONS ASSOCIATED WITH BRINGING FERROUS MATERIALS INTO THE SCAN ROOM WHILE THE MAGNET IS AT FIELD. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.

    Additional Manufacturer Narrative · 0

    LEGAL MANUFACTURER: HCS TIANJIN - NO.266 JINGSAN ROAD, TIANJIN AIRPORT ECONOMIC AREA CHINA TIANJIN TIANJIN, 300308. 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

    IT WAS REPORTED THAT A NURSE ENTERED THE MR SCAN ROOM WITH A PORTABLE OXYGEN TANK THAT WAS FERROMAGNETIC, RESULTING IN IT BECOMING ATTRACTED AND ATTACHED TO THE MAGNET. THE NURSE ATTEMPTED TO PREVENT THE OXYGEN TANK FROM BEING PULLED INTO THE MAGNET, AND IN DOING SO, SUSTAINED A DISLOCATION OF THE MIDDLE FINGER/THIRD DIGIT. THE INJURY WAS TREATED WITH A CLOSED REDUCTION PROCEDURE. THE PATIENT POSITIONED WITHIN THE MR SYSTEM AT THE TIME WAS NOT HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84600 NA NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA EXPLORER

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other