BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ONE

    MDR report key: 17297389 · Received July 11, 2023

    Report

    Report Number
    3004754211-2023-00002
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 15, 2023
    Report Date
    September 22, 2023
    Manufacturer
    SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.
    Product Code
    OWB
    PMA / PMN Number
    K133580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED WITH THE FOLLOWING RESULT. LOG ANALYSIS HAS BEEN PERFORMED AND IT SHOWED THAT ON (B)(4) 2023, PATIENT REGISTRATION WAS DONE AT 12:38:26, AND X-RAY RELEASE OCCURRED AT 12:52:46. AT 13:28:33, DOSE LESS THAN 5%¿ ERROR WAS DETECTED BY THE SYSTEM. X-RAY DATA SHOWED THE TUBE CURRENT FOR THIS FLUORO WAS 1MA. FROM THIS POINT, ALL FLUOROS WITH SMALL FOCUS EXPERIENCED THE SAME ISSUE. ACQUISITION BY LARGE FOCUS WAS CONTINUALLY RELEASED UNTIL 14:05:22. SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE SITE TO CHECK THE SYSTEM AND REPLACE THE X-RAY TUBE TO SOLVE THE ISSUE. THE REPLACED X-RAY TUBE WAS RETURNED TO SUPPLIER FOR FURTHER INVESTIGATION. IT WAS CONFIRMED THAT THE X-RAY TUBE SMALL FOCUS WAS DEFECTIVE. THE INVESTIGATION SHOWED THAT THE SMALL EMITTER (F1) HAD BEEN TOUCHING THE FOCAL HEAD. THE FOCAL TRACK AND THE SMALL EMITTER (F1) WERE OVERLOADED. IN NORMAL CONDITION, AN EMITTER HAS EQUAL DISTANCES TO THE BOUNDARY PLATES IN ALL CIRCUMSTANCES. IF THE DISTANCES ARE NOT SYMMETRIC, IT IS PROBABLE THAT THE EMITTER EXTENDS ON THERMAL LOAD AND THEN MAY TOUCH THE FOCAL BOUNDARY, WHICH CAN CAUSE VARIOUS ISSUES INCLUDING ARCING EVENTS. CONSIDERING THE OPERATION TIME OF THIS XTA OF ONLY FIVE MONTHS WITH A LOAD VALUE OF APPROXIMATELY 39000 LU, IT IS CONSIDERED THAT THE EMITTER EXPERIENCED AN EARLY WEAR-OUT. ACCORDING TO SUPPLIER FEEDBACK, NO SYSTEMATIC FAILURE IS DETECTED FOR X-RAY TUBE CURRENTLY AND NO FURTHER ACTIONS ARE NECESSARY. GENERALLY, SYSTEM HAS A MECHANISM TO SWITCH TO LARGE FOCUS AUTOMATICALLY FOR FLUORO IF SMALL FOCUS DOES NOT WORK. TECHNICALLY WHEN PUN DETECTS SMALL FOCUS FAILURE THREE TIMES, IT SENDS CORRESPONDING ERROR CODE TO ANG, AND ANG THEN REQUESTS SYSTEM TO SWITCH OVER TO LARGE FOCUS ALONG WITH A SMALL FOCUS ERROR MESSAGE REPORTED AT THE SAME TIME. WHILE IN THIS CASE IT WAS FOUND THAT NO SMALL FOCUS ERROR MESSAGE WAS EVER REPORTED TO THE SYSTEM, INDICATING PUN FAILED TO DETECT CONTINUOUS SMALL FOCUS FAILURE THREE TIMES. THE INSUFFICIENT DETECTION OF SMALL FOCUS FAILURE WAS PROBABLY CAUSED BY THE VERY LOW FRAME RATE (3 F/S) APPLIED FOR CARDIAC FL AND DISCONTINUOUS SHORT-TIME FLUORO PRESSING, RESULTING IN NO TRIGGER FOR SMALL FOCUS ERROR MESSAGE REPORTING TO SYSTEM, EVENTUALLY MADE NO AUTOMATIC SYSTEM SWITCHOVER TO USE LARGE FOCUS FOR FLUORO. THIS IS A SINGLE NON-SUCCESSFUL AUTOMATIC SWITCHOVER CASE FROM THE FIELD WITHOUT ANY SIMILAR OBSERVATIONS. DUE TO CRITICAL PATIENT SITUATION (VESSEL SUDDENLY GOT RUPTURED), CUSTOMER APPLIED ACQUISITION TO SAVE THE PATIENT AND STOPPED THE PROCEDURE AFTER THE PATIENT SITUATION WAS STABLE. ACCORDING TO THE EXAM PROTOCOL, MAINLY 88 FLUOROS AND 113 ACQUISITIONS WERE PERFORMED AT THICK WATER VALUE (33~45CM), AND LARGE SOURCE-IMAGE DISTANCE (SID, 117CM) DURING THE LONG TREATMENT PERIOD OF MORE THAN 1 HOUR WITH A CUMULATIVE SKIN DOSE OF 11GY. THE APPLIED DOSE WAS REAL-TIME DISPLAYED ON THE SCREEN IN THE EXAMINATION ROOM AND ON THE CONTROL ROOM MONITOR. THIS WOULD HAVE ALLOWED THE USER TO RECOGNIZE POTENTIALLY HIGHER DOSE DURING EMERGENCY PATIENT PROCEDURE. SIEMENS CONTINUED TO MONITOR FOR ANY FEEDBACK REGARDING THE PATIENT STATUS, AND UNTIL NOW WE HAVE NOT RECEIVED INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT FROM THE CUSTOMER SITE. NO SIMILAR ISSUE WAS OBSERVED FROM OTHER SYSTEMS IN THE FIELD. A POSSIBLE INCREASED OCCURRENCE OR A SYSTEMATIC ISSUE, WHICH LEADS TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE IDENTIFIED BY THE INVESTIGATION.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ONE SYSTEM. DURING A CARDIAC CATHETERIZATION PROCEDURE, NO FLUORO WAS AVAILABLE. THE USER HAD TO PROCEED WITH THE EXAMINATION BY PERFORMING ACQUISITION. IT IS SUSPECTED THAT HIGH RADIATION DOSE WAS APPLIED TO THE PATIENT. THERE ARE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147529 ARTIS ONE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. 10848600

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown