BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 16573944 · Received March 20, 2023

    Report

    Report Number
    1000513161-2023-00011
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 20, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    UDI-DI
    04540217059379
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ON FEBRUARY 21, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FDR GO PLUS E. IT WAS REPORTED THAT A 6-MONTH-OLD INFANT RECEIVED ONE ADDITIONAL IMAGING SCAN AT A HIGHER EXPOSURE RATE. THE TECHNICIAN PERFORMED THE INITIAL SCAN AT A RATE OF 80KV AND 14 MAS WHICH WAS THE RATE USED ON AN ADULT PATIENT PRIOR. THE TECHNICIAN NOTICED THAT THE KV AND MAS WERE INCORRECTLY SET FOR AN INFANT SCAN AND A SECOND EXPOSURE WAS RETAKEN AT THE CORRECTED RATE OF 63KV AND 1.6 MAS. 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 IS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910406 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