BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRIS ELITE MR SYSTEM

    MDR report key: 13689211 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00015
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    July 1, 2020
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON JULY 06, 2020, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC.) RECEIVED A COMPLAINT REGARDING AIRIS ELITE MR SYSTEM. THIS REPORT IS IN REGARDS TO ONE (CASE 2) OF 2 SEPARATE CASES REPORTED WITH CONFIRMED MISDIAGNOSIS. THE SITE REPORTED IMAGE BEGAN FLIPPING LEADING TO THE MISDIAGNOSIS AS A RESULT OF HEAD VIEW BEING SET TO THE TOP INSTEAD OF BOTTOM (MANUFACTURER'S RECOMMENDATION). THIS PATIENT RECEIVED SCAN ON (B)(6) 2020, AND AN AMENDMENT TO THE ORIGINAL REPORT WAS REQUIRED TO CORRECTLY IDENTIFY THE LATERALITY OF A DERMOID TUMOR IN THE BRAIN, WHICH WAS COMPARED TO A PREVIOUS STUDY DONE ON THE SAME PATIENT. THERE IS NO INFORMATION AVAILABLE WITH REGARDS TO THE CHANGE IN TREATMENT PLANS OR PATIENT'S CONDITION DUE TO MISDIAGNOSIS. THERE IS NO DEATH OR SERIOUS INJURY ASSOCIATED WITH EVENT. 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
    1337699 AIRIS ELITE MR SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE. LNH FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Other