BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEPHANIX

    MDR report key: 22506256 · Received July 15, 2025

    Report

    Report Number
    3006972752-2025-00001
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 15, 2025
    Manufacturer
    STEPHANIX
    Product Code
    OWB
    UDI-DI
    03664049001052
    PMA / PMN Number
    K213479
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A MOVEMENT ORDERED FROM THE CONSOLE BY A RADIOLOGY OPERATOR, THE TABLE DID NOT STOP. NO PATIENT, NO INJURY. THE USER DID NOT USE THE EMERGENCY STOP BUTTONS. AFTER ANALYSIS OF THE LOGS BY OUR SUPPORT TEAM, WE FOUND THAT WHEN THE TILTING CONTROL WAS RELEASED, A BUG OCCURRED IN THE INVERTERS AND MOVEMENT CONTINUED WITHOUT REACHING THE LIMIT SWITCH. WE HAVE IMPLEMENTED A HARDWARE SAFETY WHICH MONITORS IF AN ABNORMAL SITUATION LIKE THIS OCCURS AND CUTS THE POWER SO THAT THE MOVEMENT STOPS IMMEDIATELY. DURING THIS ISSUE, THE CONTACTOR FAILED TO OPEN PROPERLY AND THE EQUIPMENT REMAINED POWERED. OUR TECHNICAL TEAM ADJUSTED THE LIMIT SWITCH AND CHANGED THE CONTACTOR (MANUFACTURED BY SCHNEIDER ELECTRIC), THE COMPONENT THAT CUTS OFF THE POWER WHEN THE PROBLEM OCCURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128073 STEPHANIX IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB STEPHANIX D2RS TYPE 9090 03664049001052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown