BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q BIPLANE

    MDR report key: 10828719 · Received November 12, 2020

    Report

    Report Number
    3004977335-2020-52628
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Date of Event
    October 23, 2020
    Report Date
    November 12, 2020
    Manufacturer
    SIEMENS HEALTHCARE GMBH- AT
    Product Code
    OWB
    UDI-DI
    04056869009995
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS, SYSTEM HISTORY, SIMULATION IN THE FACTORY AND SYSTEM LOG FILES. THIS SYSTEM WAS INSTALLED IN (B)(6)2015 AND HAD NO DOSE RELEVANT ISSUE REPORTED BEFORE. THE ISSUE WAS REPORTED BY A PHYSICIST WHO WAS PERFORMING TEST RUNS ON THE SYSTEM. IN DETAIL, WHEN THE PHYSICIST PERFORMED A VERY RARE TEST CASE ALONG WITH A RARE USE CASE (NOT DURING CLINICAL EXAMINATION), THE PHYSICIST REALIZED THAT THE AIR KERMA RATES MEASUREMENT MAY EXCEED REGULATORY LIMITS. SIMULATION WAS PERFORMED IN THE FACTORY TO REENACT THE SITUATION COMMUNICATED. BASED ON THE SIMULATION, THE FOLLOWING WAS FOUND BY TECHNICAL EXPERTS. THE ISSUE ONLY OCCURRED ONCE UNDER A SPECIFIC TEST SITUATION AND CONDITION CREATED BY THE PHYSICIST ON SITE (NO CLINICAL EXAMINATION): SITUATION: - LONGTIME FLUOROSCOPY; - ACTIVE FOCUS SWITCH FROM MICRO TO SMALL, THE ORGAN PROGRAM (OGP) IS ACTIVE; - SOURCE-TO-IMAGE DISTANCE (SID) IS REDUCED; - WATER VALUE IS CHANGED IN A WAY THAT JUST TRIGGER THE AUTO-FOCUS-SWITCH; CONDITION: - SYSTEM WITH 3-FOCUS TUBE; - THE AMOUNT OF DOSE IS DISPLAYED ALL THE TIME; - THE ISSUE CAN BE RESOLVED ANY TIME ONCE FRAME RATE OR OGP IS CHANGED. FURTHERMORE, TECHNICAL EXPERTS INSPECTED FIELD LOGS OF SEVERAL MILLION SCENES OF SIMILAR SYSTEMS AND COULD NOT CONFIRM ANY SERIOUS ANOMALY OR GENERAL SYSTEMATIC ISSUES. IN ANY SITUATION THE CURRENT DOSE RATES ARE INDEPENDENTLY MEASURED BY AN IONIZATION CHAMBER AND DIRECTLY DISPLAYED ON THE LIVE MONITOR SO THAT THE OPERATOR HAS FULL FEEDBACK ON THE AMOUNT OF DOSE HE IS APPLYING AT ALL TIMES. THIS IS THE FIRST TIME THIS ISSUE HAS BEEN REPORTED AND IT WAS FOUND DURING THE PHYSICS TEST. A FUTURE CORRECTION FOR THE ISSUE IDENTIFIED IS STILL UNDER CONSIDERATION. AS THE ISSUE ONLY OCCURRED UNDER SPECIAL TEST CONDITIONS AND NOT IN REGULAR PATIENT OPERATION, THE CUSTOMER CAN AVOID THE MENTIONED TEST PROBLEM AND CONTINUE TO WORK WITH THE SYSTEM. AFTER DETAILED INVESTIGATION, THE INCIDENT IS NOT CLASSIFIED AS A REPORTABLE EVENT AS NEITHER SERIOUS INJURY, DEATH NOR AN UNEXPECTED PROLONGED HOSPITALIZATION OF THE PATIENT OR ANY OTHER PERSON OCCURRED OR COULD BE EXPECTED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q BIPLANE SYSTEM. THE USER REPORTED THAT DURING TESTING FOR MAX DOSE DURING CERTAIN CONDITIONS, THE DOSE REGULATION DOES NOT INHIBIT THE MAX DOSE TO ACCEPTABLE LIMITS. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER 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
    1295123 ARTIS Q BIPLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH- AT 10848282 04056869009995

    Patients

    Seq Age Sex Outcome Treatment
    1