BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 17282916 · Received July 7, 2023

    Report

    Report Number
    1000513161-2023-00042
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 9, 2023
    Report Date
    July 7, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON JUNE 9, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT A MINOR PATIENT WAS OVEREXPOSED DURING A CHEST X-RAY. THE EXPOSURE INDEX WAS INTENDED TO BE AT A LEVEL OF 200, BUT THE EXPOSURE INDEX DURING THE SCAN WAS 1787. IT IS UNCLEAR IF THE ADDITIONAL EXPOSURE COULD LEAD TO A SAFETY RISK. THEREFORE, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION. THERE WAS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039994 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 7 YR Male