BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON OVAL

    MDR report key: 13688718 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00007
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    December 30, 2020
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    LNH
    UDI-DI
    04580292768391
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    ON JANUARY 06, 2021, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC.) RECEIVED A COMPLAINT REGARDING ECHELON OVAL MRI. THE SITE REPORTED THAT A PATIENT RECEIVED A CERVICAL MRI ON (B)(6) 2020. SINCE THE RADIOLOGIST WERE NOT SATISFIED WITH THE IMAGE QUALITY, PATIENT WAS RESCANNED AT ANOTHER FACILITY, USING A DIFFERENT SYSTEM. PRIOR TO THIS PATENT WAS DIAGNOSED WITH MULTIPLE SCLEROSIS ON (B)(6) 2018 ON AN OEM SYSTEM AT ANOTHER SITE. THE PATIENT WAS SCANNED ON THE OEM SYSTEM ON (B)(6) 2021. THE RADIOLOGIST USED THIS SET OF IMAGES AND COMPARED IT TO THE ORIGINAL IMAGES FROM (B)(6) 2018. THE RADIOLOGIST AMENDED THE REPORT FROM (B)(6) 2020. PATIENT'S CONDITION AND TREATMENT INFORMATION WERE NOT RELEASED. DURING A RETROSPECTIVE REVIEW, IT WAS DISCOVERED THAT THE MANUFACTURER HAD ASSESSED THIS EVENT AS AE LEADING TO SERIOUS INJURY; THEREFORE AN IMPORTER'S MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167120 ECHELON OVAL MAGNETIC RESONANCE DIAGNOSTIC DEVICE. LNH FUJIFILM HEALTHCARE CORPORATION N/A N/A 04580292768391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other