BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTIS ZEEGO

    MDR report key: 7568516 · Received June 5, 2018

    Report

    Report Number
    3004977335-2018-32918
    Event Type
    Injury
    Date Received
    June 5, 2018
    Date of Event
    May 31, 2018
    Report Date
    May 31, 2018
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K141574
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. ASSESSMENT OF THE LOG FILES DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. CONSIDERING THE COMPLAINT DESCRIPTION, ACTUAL SERVICE REPORTS, THE SYSTEM LOG FILES AND THE SYSTEM HISTORY THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE INVESTIGATION OF THE LOG FILES SHOWED THAT ROBOTIC STAND MOVEMENT WAS POSSIBLE AT ALL THE TIME DURING THE PROCEDURE. THE CSE REPORTED THAT THE ROBOTIC STAND WAS MOVED OUT OF THE NORMAL OPERATION ZONE BY A NURSE. ACCORDING TO THE LOG FILES, THE ROBOTIC STAND WAS MOVED INTO A SAFETY ZONE WHERE ONLY SLOW MOVEMENTS ARE ALLOWED BECAUSE OF THE PROXIMITY TO A KNOWN OBSTACLE OR TO THE PATIENT. BETWEEN 12:29 AND 12:35 THE USER INITIATED ROBOTIC STAND MOVEMENTS MANUALLY VIA THE JOYSTICK ON THE STAND CONTROL MODULE BUT RELEASED IT AFTER 2-3 SECONDS. DUE TO THE INERTIA OF THE ROBOTIC STAND AND THE SAFETY SOFTWARE IMPLEMENTED ON THE COLLISION COMPUTER, ROBOTIC STAND MOVEMENT CANNOT BE INITIATED AFTER SUCH A SHORT AMOUNT OF TIME. THEREFORE, THE USER MIGHT HAVE HAD THE IMPRESSION THAT ROBOTIC STAND MOVEMENT WAS NOT AVAILABLE BUT IN FACT IT WAS POSSIBLE AT ALL TIMES DURING THE PROCEDURE. IF THE USER WOULD HAVE NOT RELEASED THE JOYSTICK THE ROBOTIC STAND WOULD HAVE MOVED. IN THE PRESENT CASE THE MOVEMENT OF THE ROBOT USING THE KCP WAS NOT NECESSARY. THE KCP SHALL ONLY BE USED BY TRAINED PERSONAL AS THIS UNIT IS USED FOR MASTERING, PROGRAMMING AND MOVING THE ROBOT AS INTENDED BY KUKA. THE LOG FILES ALSO SHOWED THAT THE USER INITIATED SEVERAL RESETS OF THE STAND CONTROL UNIT (SCU) WHICH WOULD NOT RESOLVE THE ISSUE. IN ADDITION, THE USER INITIATED MOVEMENTS OF THE ROBOTIC STAND BEFORE THE SCU WAS COMPLETELY READY AFTER THE RESET. IN GENERAL, SYSTEM FUNCTIONALITY IS ONLY AVAILABLE AFTER THE SYSTEM IS FULLY UP AND RUNNING. THE SYSTEM WORKED AS SPECIFIED AND AS DESCRIBED IN THE INSTRUCTIONS FOR USE. THE OPERATORS MANUAL CONTAINS CLEAR AND SUFFICIENT INSTRUCTIONS HOW TO INITIATE MOVEMENTS OF THE ROBOTIC STAND. THE LOCAL TECHNICIANS RESOLVED THE ISSUE USING THE ROBOTS CONTROL PAD (KCP) PROVIDED BY KUKA AND RESTARTED THE SYSTEM. NO FIELD SAFETY CORRECTIVE ACTION IS PLANNED BASED ON THE PRESENT EVENT.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2017017. (B)(4). SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE ROBOT WAS MOVED OUT OF THE SAFE ZONE AND ALL SYSTEM MOVEMENTS STOPPED, RESULTING IN A DELAY IN PROCEDURE. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT PASSED AWAY DURING THE PROCEDURE. THE USER REPORTED THAT THE ARTIS ZEEGO SYSTEM DID NOT MAKE ANY CONTACT WITH THE PATIENT. ADDITIONALLY, THE PATIENT'S CONDITION PRIOR TO EXAMINATION OR TYPE OF PROCEDURE BEING PERFORMED IS NOT YET KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414000 ARTIS ZEEGO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10280959

    Patients

    Seq Age Sex Outcome Treatment
    1 Death