BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRIS II MRI SYSTEM

    MDR report key: 13689175 · Received March 8, 2022

    Report

    Report Number
    1528028-2022-00006
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    December 3, 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 JANUARY 06, 2021, DECEMBER 07, 2020, FUJIFILM HEALTHCARE AMERICAS CORPORATION (FORMERLY HITACHI MEDICAL SYSTEMS AMERICA, INC.) RECEIVED A COMPLAINT REGARDING AIRIS II MRI SYSTEMS. THE SITE REPORTED THAT A PATIENT RECEIVED A SCAN FOR HER ELBOW ON (B)(6) 2020. THE PATIENT CALLED THE SITE ON DECEMBER 4TH, TO REPORT THAT SHE HAD RECEIVED A BURN SIMILAR TO A SUNBURN ON HER BACK AND BOTH ARMS AND HAS VISITED THE URGENT CARE. THE SITE ASKED WHAT PORTION OF THE ARMS WERE BURNED BUT THE PATIENT DID NOT DIVULGE THE INFORMATION. THE PATIENT ALSO DID NOT PROVIDE PICTURES OF THE BURN WHEN ASKED BY THE SITE NOR DID SHE REVISIT THE SITE FOR PHYSICIAN TO CHECK HER BURNS. THE PATIENT ALSO DID NOT PROVIDE INFORMATION ON WHETHER SHE RECEIVED TREATMENT FOR THE BURN INJURY. 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
    1654516 AIRIS II MRI SYSTEM MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH FUJIFILM HEALTHCARE CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other