BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 17666499 · Received August 31, 2023

    Report

    Report Number
    1000513161-2023-00058
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    August 2, 2023
    Report Date
    August 31, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    UDI-DI
    05402170593792
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON (B)(6), 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUSE. IT WAS REPORTED THAT THE COLLIMATOR RIG IS LOOSE, AND THIS IS A PATIENT SAFETY HAZARD. THERE IS NO ADDITIONAL INFORMATION PROVIDED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. AS SUCH, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182751 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION 16580911 N/A 05402170593792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown