BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 17869535 · Received October 4, 2023

    Report

    Report Number
    1000513161-2023-00068
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 5, 2023
    Report Date
    October 4, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    UDI-DI
    05402170593792
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2023 FUJIFILM CORPORATION WAS INFOMRED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT THE DEVICE HAD AN A10 ERROR CODE. THE SYSTEM WAS UNABLE TO BE MOVED DURING A TRAUMA AND THE EMERGENCY SWITCH WAS NOT WORKING EITHER. SINCE "TRAUMA" IS UNKNOWN, FUJIFILM IS SUBMITTING THIS MDR AN AN IMPORTER WITH ABUNDANCE OF CAUTION. THERE WAS NO PATIENT HARM OR INJURY REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1627027 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION 16580911 05402170593792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown