BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTAIRE MR SYSTEM

    MDR report key: 13689527 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00002
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    March 16, 2020
    Report Date
    March 7, 2022
    Manufacturer
    FUJIFILM HEALTHCARE CORPORATION
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2020, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC.) RECEIVED A COMPLAINT REGARDING ALTAIRE MR SYSTEM. THE SITE REPORTED BRAIN IMAGES WERE FLIPPED (RIGHT-LEFT LATERALITY). THE ORIGINAL RADIOLOGY REPORT STATES THE PATIENT HAD AN ACUTE-EARLY SUBACUTE INFARCT IN THE POSTERIOR LEFT FRONTAL WHITE MATTER AND SUSPECT TINY OLD LACUNAR INFARCTS IN THE BILATERAL BASAL GANGLIA AND LEFT PONS. THE ADDENDUM STATES, AN ACUTE-EARLY SUBACUTE INFARCT IN THE POSTERIOR RIGHT FRONTAL WHITE MATTER AND SUSPECT TINY OLD LACUNAR INFARCTS IN THE BILATERAL BASAL GANGLIA AND RIGHT PONS. THIS PATIENT WAS TREATED WITH PLAVIX, ATORVASTATIN AND ASPIRIN. TREATMENT WAS NOT AFFECTED AND WOULD NOT HAVE CHANGED. THERE IS NO DEATH 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 MDR IS BEING SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1311983 ALTAIRE MR SYSTEM SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING LNH FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Other