BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 16457706 · Received February 28, 2023

    Report

    Report Number
    1000513161-2023-00010
    Event Type
    Malfunction
    Date Received
    February 28, 2023
    Date of Event
    January 30, 2023
    Report Date
    February 28, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON JANUARY 30, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT AN ARTIFACT APPEARED ON THE DEVICE COVERING HALF OF THE IMAGE WHICH LEAD TO ONE ADDITIONAL EXPOSURE OF A MINOR PATIENT. THE TOTAL MAS AND KVP OF THE OVERALL EXPOSURE RATE IS UNKNOWN AND 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
    1123521 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