BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 18454759 · Received January 5, 2024

    Report

    Report Number
    1000513161-2024-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    December 13, 2023
    Report Date
    January 5, 2024
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF COMP (B)(4).

    Description of Event or Problem · 0

    ON DECEMBER 12TH, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT ON THE TUBE HOUSING IT IS EXTREMELY LOOSE, AND IT NEEDS TO BE REPLACED. IT IS A SAFETY ISSUE IT COULD COME A LOOSE AND FALL ON A PATIENT. THERE IS NO HARM TO THE PATIENT REPORTED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675885 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR GO PLUS E N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown