BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 23189933 · Received October 1, 2025

    Report

    Report Number
    3010949642-2025-00005
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    July 8, 2025
    Report Date
    December 15, 2025
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K211980
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2, 3, 6. H3: GE HEALTHCARE (GEHC) HAS COMPLETED ITS INVESTIGATION. THE MR SYSTEM WAS EVALUATED AND CONFIRMED TO BE OPERATING WITHIN SPECIFICATIONS AND COMPLIANT WITH (B)(4). ALL SAFETY MITIGATION DEVICES WERE FULLY FUNCTIONAL WHEN INSPECTED BY THE GEHC FIELD ENGINEER. BASED ON CUSTOMER-PROVIDED INFORMATION, GEHC CONFIRMED THAT THE PATIENT WAS PADDED FOR THE MR EXAM; HOWEVER, THE PADDING WAS INCORRECTLY POSITIONED, RESULTING IN THE PATIENT DIRECTLY CONTACTING THE BORE WALL OF THE MR SYSTEM. THE ROOT CAUSE OF THE INJURY WAS IMPROPER USE OF PADDING DURING THE MR EXAM. OPERATOR DOCUMENTATION AND THE USER INTERFACE DESCRIBE THE CORRECT SAFETY MEASURES FOR PADDING PATIENTS. THE MR OPERATOR IS RESPONSIBLE FOR USING AND POSITIONING NON-CONDUCTIVE, MR-COMPATIBLE PADDING AND PREPARING THE PATIENT PRIOR TO STARTING THE EXAM. NO FURTHER ACTIONS ARE 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 TO GE HEALTHCARE (GEHC). 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 A PATIENT SUSTAINED A 4-5CM, PARTIAL THICKNESS BURN ON THE LEFT ELBOW DURING MR EXAMINATION OF THE LEFT SHOULDER. TREATMENT OF THE BURN INJURY HAS INCLUDED DEBRIDEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2014452 NA NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED SIGNA PRIME

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other