BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANON

    MDR report key: 19347531 · Received May 17, 2024

    Report

    Report Number
    2020563-2024-00004
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    April 19, 2024
    Report Date
    April 25, 2024
    Manufacturer
    CANON MEDICAL SYSTEMS CORPORATION
    Product Code
    IXR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT WAS CAUSED BY A RADIOLOGY TECHNICIAN OPERATING THE X-RAY DIAGNOSTIC TABLE WITHOUT FOLLOWING THE PRECAUTIONS DESCRIBED IN OPERATING MANUAL.

    Description of Event or Problem · 0

    ON (B)(6) 2024 A RADIOLOGY TECHNICIAN WAS SECURING A PATIENT TO THE TABLE, WHILE THE TABLE WAS IN A VERTICALLY TILTED POSITION. AT THE TIME OF THE INCIDENT THE TECHNICIAN WAS STANDING BEHIND THE TABLE AT THE FOOT END WITH HER FOOT ON THE TABLE SUPPORT BASE. THE TECHNICIAN FOOT WAS CRUSHED BY THE LOWER BEARING GUIDE WHICH COMES TO WITHIN AN INCH OF THE BASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855689 CANON IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM IXR CANON MEDICAL SYSTEMS CORPORATION DUA-450F

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other