BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 16667970 · Received April 3, 2023

    Report

    Report Number
    1000513161-2023-00017
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 3, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    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 PLUS E. IT WAS REPORTED THAT THE USER NOTICED THE POWER CABLE ON THE UNIT WAS MELTED PRIOR TO BEGINNING AN IMAGING STUDY ON A PATIENT. THERE WAS A SLIGHT DELAY IN IMAGING. THE PATIENT STUDY WAS COMPLETED SUCCESSFULLY USING A SECONDARY MACHINE. THERE IS NO 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
    581617 FDR GO PLUS E SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown