BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 22035997 · Received May 16, 2025

    Report

    Report Number
    1000513161-2025-00018
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Report Date
    May 16, 2025
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    UDI-DI
    04540217059379
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF COMP # (B)(4). THE RESOLUTION WAS TO REBUILD THE PLUG ON THE CORD REEL, TEST THE PLUG AND CHARGING CIRCUIT, WHICH TESTED GOOD. THE UNIT IS WORKING AS DESIGNED.

    Description of Event or Problem · 0

    ON APRIL 16TH, 2025, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. THE ISSUE WAS THAT THE PLUG MAY NOT BE GROUNDED, SPARKING INSIDE OF CLEAR HOUSING AND CAUSING THE PLUG TO HEAT UP. THE INJURY TO THE USER OR ANY PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED AT THIS TIME. THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1880655 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR GO PLUS E UNKNOWN 04540217059379

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown