BEUDAMED
    FDA Adverse Event Death Summary report: N

    FDR GO PLUS

    MDR report key: 15280406 · Received August 23, 2022

    Report

    Report Number
    1000513161-2022-00012
    Event Type
    Death
    Date Received
    August 23, 2022
    Date of Event
    August 8, 2022
    Report Date
    August 23, 2022
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Adverse Event
    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) 2022, FUJIFILM HEALTHCARE AMERICAS CORPORATION BECAME AWARE OF AN EVENT INVOLVING FDR GO PLUS. IT WAS REPORTED THAT THE SUBJECT DEVICE MALFUNCTIONED WHILE PERFORMING AN ABDOMINAL X-RAY EXAM ON A TRAUMA PATIENT, AND THE UNIT DID NOT TAKE THE EXPOSURE. THE PATIENT DIED BEFORE THE STAFF WAS ABLE TO TAKE AN EXPOSURE USING A SECONDARY MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478788 FDR GO PLUS MOBILE X-RAY SYSTEM IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death