BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FDR GO PORTABLE IMAGING UNIT X-RAY MACHINE

    MDR report key: 18421519 · Received December 29, 2023

    Report

    Report Number
    1000513161-2023-00084
    Event Type
    Malfunction
    Date Received
    December 29, 2023
    Date of Event
    September 8, 2023
    Report Date
    December 29, 2023
    Manufacturer
    SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REF (B)(4).

    Description of Event or Problem · 0

    ON DECEMBER 20TH 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING FUJI - FDR GO PORTABLE IMAGING UNIT X-RAY MACHINE. IT WAS REPORTED THAT A PORTABLE CHEST WAS PERFORMED, AND THE IMAGE WOULD NOT CROSS INTO PACS. THERE WAS TROUBLESHOOTING THAT WAS ATTEMPTED BUT FAILED. THE IMAGE WAS REPEATED. THERE WAS NO PATIENT HARM OR INJURY REPORTED. THERE IS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2285653 FDR GO PORTABLE IMAGING UNIT X-RAY MACHINE SYSTEM, X-RAY, MOBILE IZL SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION FDR GO PORTABLE IMAGING UNIT X-RAY MACHINE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown