BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ICONOS R200

    MDR report key: 8514017 · Received April 15, 2019

    Report

    Report Number
    3004977335-2019-77543
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    April 4, 2019
    Report Date
    April 10, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    JAA
    PMA / PMN Number
    K992660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS INVESTIGATED WITH THE FOLLOWING RESULT. THE DESCRIBED BEHAVIOR WAS CAUSED BY A DE-CALIBRATED JOYSTICK. THIS BEHAVIOR COULD BE REPRODUCED AS SHOWN IN THE PROVIDED VIDEOS. FOLLOWING THE RE-ADJUSTMENT OF THE JOYSTICK BY THE SERVICE TECHNICIAN, THE ISSUE AT THE CONCERNED SITE WAS RESOLVED. THE JOYSTICK WAS LATER EXCHANGED FOLLOWING THE SUCCESSFUL RE-CALIBRATION AND REQUESTED FOR FURTHER INVESTIGATION, HOWEVER, IT WAS NOT PROVIDED DESPITE SEVERAL REQUESTS. THEREFORE, A DETAILED ANALYSIS OF THE JOYSTICK WAS NOT POSSIBLE. THE SPARE PART CONSUMPTION OF THE CONCERNED PART (CROSS SWITCH WITH POTI, MATERIAL NUMBER 7030765) SHOWS VALUES BELOW THE DEFINED THRESHOLD. IN THE MAINTENANCE INSTRUCTIONS THE ADJUSTMENT OF THE JOYSTICK IS PART OF THE REQUIRED ACTIONS (SEE XPD3-340.831.20.07.02, CHAPTER 5.2.12.2 OPTIONS, CHECKING THE UNIT CONTROL CONSOLE FOR FUNCTION AND DAMAGE).

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE REPORTED EVENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(6).

    Description of Event or Problem · 1

    SIEMENS BECAME AWARE OF UNINTENDED SYSTEM MOVEMENT OF THE AXIOM ICONOS R200. DURING A PROCEDURE THE OPERATOR NOTICED THAT THE TABLE SLOWLY TILTED WITHOUT ANY CONTROL KEY OR LEVER BEING TOUCHED ON THE CONTROL DESK. THE MOVEMENT WAS PERFORMED TOWARDS THE HEAD POSITION FROM 0° (TABLE HORIZONTAL) TO MINUS DEGREES. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT. THE REPORTED EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308427 AXIOM ICONOS R200 IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM JAA SIEMENS HEALTHCARE GMBH 10093962

    Patients

    Seq Age Sex Outcome Treatment
    1 Other