BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEEGO III

    MDR report key: 20168211 · Received September 9, 2024

    Report

    Report Number
    3004977335-2024-00110
    Event Type
    Malfunction
    Date Received
    September 9, 2024
    Date of Event
    August 20, 2024
    Report Date
    September 27, 2024
    Manufacturer
    SIEMENS AG
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE BUT IS SIMILAR TO THE ARTIS ZEE DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE EVENT. THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS, SYSTEM HISTORY, AND SYSTEM LOG FILES. ACCORDING TO THE INITIAL INFORMATION, THE SYSTEM ENCOUNTERED RESTRICTED MOVEMENT DURING USE, ALLOWING ONLY SLOW MOVEMENT. HOWEVER, X-RAYS REMAINED AVAILABLE, AND SYSTEM MOVEMENT WAS STILL POSSIBLE AT A REDUCED SPEED. THE PATIENT WAS TRANSFERRED TO AN ALTERNATIVE SYSTEM TO COMPLETE THE PROCEDURE WITHOUT ANY REPORTED HEALTH CONSEQUENCES. UPON INVESTIGATION, THE SIEMENS ENGINEER IDENTIFIED THAT THE POTENTIOMETER FOR THE RECEPTOR LIFT, WHICH IS RESPONSIBLE FOR PROVIDING INFORMATION ABOUT SYSTEM RECEPTOR POSITIONS, WAS NOT WORKING AS INTENDED. THE SYSTEM AUTOMATICALLY DETECTED AN ISSUE BY COMPARING THE FIRST INFORMATION SOURCE (ENCODER OR POTENTIOMETER) WITH THE SECOND INFORMATION SOURCE (SECOND POTENTIOMETER). WHEN A SIGNIFICANT DEVIATION WAS DETECTED, THE SYSTEM CHANGED TO REDUCED SPEED, AND THE CORRESPONDING MESSAGE "STAND/TABLE ERROR, USE EMERG. STOP TO RESET" WAS DISPLAYED TO THE CUSTOMER. THE SIEMENS ENGINEER EXCHANGED THE POTENTIOMETER. AFTER THAT, THE SYSTEM RECOVERED. AN EXTENSIVE INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE POTENTIOMETER WAS NOT RETURNED FOR A DETAILED INVESTIGATION. AFTER HARDWARE REPLACEMENT, THERE WERE NO FURTHER ISSUES AS DESCRIBED IN THE COMPLAINT DESCRIPTION AND THE SYSTEM WORKS AS INTENDED. THE RELEVANT ROOT CAUSE FOR THE NON-CONFORMITY WAS DETERMINED TO BE A DEFECTIVE POTENTIOMETER. THE OCCURRENCE RATE OF THE ERROR PATTERN WAS CHECKED. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH WOULD LEAD TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE DETERMINED BY THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO III SYSTEM. THE USER REPORTED THAT DURING AN EMERGENCY PATIENT PROCEDURE, THE SYSTEM COULD NOT BE MOVED TO THE DESIGNATED POSITION. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537381 ARTIS ZEEGO III INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS AG 10502505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown