BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PLUS E

    MDR report key: 17336869 · Received July 17, 2023

    Report

    Report Number
    1000513161-2023-00041
    Event Type
    Malfunction
    Date Received
    July 17, 2023
    Date of Event
    June 22, 2023
    Report Date
    July 17, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NH, 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 A NEWBORN INFANT WAS SCANNED AT A RATE OF 80KV/16MAS WHEN THE RATE SHOULD HAVE BEEN 60KV/1MAS. A SECOND EXPOSURE WAS TAKEN AT THE CORRECT RATE OF 60KV/1MAS. THERE WAS NO SERIOUS INJURY OR DEATH ASSOCIATED WITH THE EVENT. IT IS UNCLEAR IF THE HIGHER EXPOSURE LEVEL COULD LEAD TO A SAFETY RISK. THEREFORE, THIS REPORT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1642580 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