BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 16629272 · Received March 28, 2023

    Report

    Report Number
    1000513161-2023-00015
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    March 17, 2023
    Report Date
    March 28, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    UDI-DI
    04540217059379
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, 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 PLUS E. IT WAS REPORTED THAT THE SCREWS ON THE COLLIMATOR RING ARE BECOMING LOOSE OVER TIME CAUSING THE COLLIMATOR TO BECOME UNSTABLE. THERE IS NO PATIENT INVOLVEMENT OR REPORT OF SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. THEREFORE, THIS REPORT IS BEING SUBMITTED IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554527 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION N/A N/A 04540217059379

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown