BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON XL MRI SYSTEM

    MDR report key: 22668220 · Received July 30, 2025

    Report

    Report Number
    1000513161-2025-00029
    Event Type
    Injury
    Date Received
    July 30, 2025
    Date of Event
    July 12, 2025
    Report Date
    September 16, 2025
    Manufacturer
    FUJIFILM CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF COMP # (B)(4).

    Description of Event or Problem · 0

    ON 07/12/2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING ECHELON XL MRI SYSTEM. DURING AN EXAM ON THE ECHELON XL MRI SYSTEM USING THE ANTERIOR COIL, THE PATIENT EXPERIENCED A BURN. THE PATIENT WAS WEARING SCRUB SHORTS. THE COIL WAS PLACED DIRECTLY ON THE PATIENT, RESULTING IN SKIN-TO-COIL CONTACT AT THE KNEE AND SKIN-TO-SCRUB SHORTS CONTACT ON THE FEMUR. 1/4" PADDING WAS NOT USED BETWEEN THE COIL AND THE PATIENT, AS OUTLINED IN FUJIFILM MR PATIENT WARMING PREVENTION PLAN. THE PATIENT SHOWED REDNESS AND A BLISTER AND DECLINED AN ICE PACK. THE TECHNOLOGIST REMOVED THE PATIENT FROM THE MACHINE, PLACED PADDING BETWEEN THE COIL AND THE PATIENT'S LEGS, AND COMPLETED THE EXAM WITHOUT FURTHER PROBLEM. DUE TO BURN TO THE PATIENT, FUJIFILM HEALTHCARE AMERICAS CORPORATION IS REPORTING THIS EVENT.

    Description of Event or Problem · 0

    REF COMP #(B)(4). UPDATE: FUJIFILM HEALTHCARE AMERICAS CORPORATION RECEIVED NEW INFORMATION FROM SERVICE THAT THE PATEINT HAD 1ST DEGREE BURN. IN SECTION F10, HEALTH EFFECT - CLINICAL CODE (E) IS UPDATED TO 2685, 4537 AND 1757. INITIAL IMPORTER MDR 1000513161-2025-00030 WAS SUBMITTED DUE TO BURN TO THE PATIENT ON (B)(6) 2025. INITIAL IMPORTER MDR 1000513161-2025-00029 IS ATTACHED IN THIS SUPPLEMENTAL REPORT (S1).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55051 ECHELON XL MRI SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH FUJIFILM CORPORATION ECHELON XL MRI SYSTEM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Other