BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ICONOS R200 C20_C

    MDR report key: 22008561 · Received May 13, 2025

    Report

    Report Number
    3004977335-2025-00062
    Event Type
    Malfunction
    Date Received
    May 13, 2025
    Date of Event
    April 30, 2025
    Report Date
    April 16, 2026
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    JAA
    UDI-DI
    04056869161648
    PMA / PMN Number
    K992660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE): CURRENTLY NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE WHICH REQUIRES AN IMMEDIATE ACTION. MANUFACTURER'S PRELIMINARY RESULTS AND CONCLUSION: THE ROOT CAUSE OF THE ISSUE HAS NOT YET BEEN IDENTIFIED. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED UPON THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3, H6: SIEMENS HEALTHINEERS COMPLETED THE INVESTIGATION OF THE REPORTED PROBLEM. IT WAS PREVIOUSLY REPORTED THAT THE PATIENT TABLE TILTED ON ITS OWN TWICE IN ONE DAY. THE VIDEOS PROVIDED CONFIRMED THE DESCRIBED SITUATIONS AND THAT NO PERSON WAS PRESENT DURING THIS TIME. IT COULD BE SEEN THAT THE TABLE TILTED FROM THE 0-DEGREE POSITION HEAD-SITE DOWNWARDS FOR ABOUT FIVE SECONDS AND THEN STOPPED BY ITSELF AT APPROXIMATELY -15 DEGREES, AS INTENDED BY THE IMPLEMENTED SAFETY MECHANISM. THE ANALYSIS OF THE LOG FILES SHOWED THAT DURING THE UNINTENDED TILTING NO LOG ENTRY WAS CREATED BY THE SYSTEM WHICH INDICATES THAT THE SYSTEM DID NOT DETECT ANY MALFUNCTION. THEREFORE, THE UNINTENDED MOVEMENT MUST BE GENERATED BY AN INDEPENDENT COMMAND EITHER BY A FAULT IN THE TABLE SIDE CONTROL (MATERIAL NUMBER 7030773), BY THE REMOTE-CONTROL DESK (MATERIAL NUMBER 7030708) OR BY THE BUC-BOARD (MATERIAL NUMBER 7033629). FOR A MORE IN-DEPTH ANALYSIS, THE POTENTIALLY AFFECTED COMPONENTS WERE REQUESTED BUT THE CUSTOMER WOULD NOT PROVIDE THE COMPONENTS AND REJECTED THE OFFER FOR REPLACEMENT OF THE COMPONENTS. THEREFORE, IT WAS NOT POSSIBLE TO DETERMINE WHICH COMPONENT CAUSED THE UNINTENDED MOVEMENT SIGNAL. SIEMENS HEALTHINEERS INTERNAL POST MARKET SURVEILLANCE DOES NOT INDICATE A GENERAL PROBLEM WITH THESE SPARE PARTS. IN GENERAL, ANY UNINTENDED SYSTEM MOVEMENT CAN ALWAYS BE STOPPED IMMEDIATELY BY PRESSING AN EMERGENCY STOP BUTTON AS DESCRIBED IN THE OPERATOR MANUAL (AXD3-340.620.14.01.02). IN THE MEANTIME, THE CUSTOMER HAS DECIDED TO REPLACE THE AFFECTED AXIOM ICONOS R200 C20_C WITH A NEW SYSTEM. THE AXIOM ICONOS R200 C20_C HAS ALREADY REACHED EOS (END OF SUPPORT) ON 2022-12-31. THE COMPLAINT WAS CLOSED. NO FURTHER ACTION IS NEEDED.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS WAS MADE AWARE OF AN ISSUE WITH THE AXIOM ICONOS R200 C20_C SYSTEM. THE CUSTOMER STATED THAT THE TABLE TILTED ON ITS OWN ON TWO OCCASIONS. NO MOVEMENT COMMAND WAS GIVEN, AND NO ONE WAS IN THE EXAMINATION ROOM DURING THE INCIDENTS. THE CUSTOMER IS USING THE SYSTEM NORMALLY SINCE THE INCIDENTS WITH NO ISSUES. NO INJURIES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193754 AXIOM ICONOS R200 C20_C SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA SIEMENS HEALTHINEERS AG 10093962 04056869161648

    Patients

    Seq Age Sex Outcome Treatment
    1