BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELUXE ULTRASOUND TABLE

    MDR report key: 19655567 · Received July 2, 2024

    Report

    Report Number
    2518443-2024-00002
    Event Type
    Injury
    Date Received
    July 2, 2024
    Date of Event
    April 24, 2024
    Report Date
    July 2, 2024
    Manufacturer
    MIRION TECHNOLOGIES (CAPINTEC) INC.
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TABLE IS ABOUT 22 YEARS OLD, AND BEYOND END OF LIFE. FACILITY WAS ADVISED TO REMOVE TABLE PERMANENTLY FROM USE. SERVICE HISTORY REQUESTED AND IS PENDING AT TIME OF THIS REPORT. RETURN OF TABLE TO MANUFACTURER WAS REQUESTED AND IS PENDING AT TIME OF THIS REPORT. THE TABLE WAS MANUFACTURED BY BIODEX MEDICAL SYSTEMS AROUND 2002. THIS MODEL WAS DISCONTINUED ABOUT 2012. THE ULTRASOUND TABLE PRODUCT LINE WAS ACQUIRED BY MIRION TECHNOLOGIES (CAPINTEC) INC. IN 2021. BIODEX IS CURRENTLY A SUBCONTRACT MANUFACTURER FOR MIRION TECHNOLOGIES FOR THIS PRODUCT LINE.

    Description of Event or Problem · 0

    ON (B)(6) 2024 PATIENT WAS UNDERGOING A US SCAN ON A DELUXE ULTRASOUND TABLE MODEL 056 605 VO. THE PATIENT SHIFTED HIS WEIGHT FROM HIS HORIZONTAL BACK POSITION TO THE RIGHT SIDE WHEN THE BACK OF THE TABLE BROKE, CAUSING THE PATIENT TO SLIP TO THE GROUND. PATIENT REPORTED A MENISCUS TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801687 DELUXE ULTRASOUND TABLE ULTRASOUND TABLE FQO MIRION TECHNOLOGIES (CAPINTEC) INC. 056-605-VO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention