BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q BIPLANE

    MDR report key: 9488506 · Received December 18, 2019

    Report

    Report Number
    3004977335-2019-09756
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 25, 2019
    Report Date
    November 25, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. IT WAS ALLEGED THAT DSA WAS "GRAINY", FLUORO WAS OF LESS CONTRAST AND HAD MORE NOISE AND THE ROADMAP WAS OF NOT OPTIMAL VISIBILITY OF DEVICE. ON THE OTHER HAND, THE CUSTOMER ALSO CLAIMED THAT DURING PROCEDURE, IN SOME CASES, SIGNIFICANT IMAGE QUALITY DEGRADATION HAD OCCURRED. NEVERTHELESS, THE INVESTIGATION SHOWED THAT THE SYSTEM WORKED AS SPECIFIED. A SERVICE TECHNICIAN WENT ON SITE AND CHECKED THE SYSTEM; HOWEVER, NO MALFUNCTION WAS IDENTIFIED. THE LOGS HAVE BEEN ANALYZED IN DETAIL AND NO ERROR HAD BEEN FOUND EITHER. THE ORGAN PROGRAMS (OGPS) USED ON SITE SHOWED ROOM FOR IMPROVEMENT AND THEY WERE ADJUSTED AND OPTIMIZED. INSTEAD OF SWITCHING BETWEEN MICRO AND SMALL FOCUS THE OGP-PROGRAM IS NOW USING THE SMALL FOCUS ONLY. IT HAD BEEN RECOGNIZED PER IQ-REPORT, THAT THE IMAGE QUALITY DEGRADATION DURING PROCEDURE MIGHT BE LINKED TO "AUTOFOCUS SWITCH BETWEEN MICROFOCUS AND SMALL FOCUS", WHICH IS AN INTENDED BEHAVIOR OF THE SYSTEM DEPENDING ON THE OGP SETTING. WITH OGPS ADJUSTMENT, THE SYSTEM NOW IS ALWAYS WORKING WITH THE SMALL FOCUS. THE OGPS WERE ADJUSTED (MICRO FOCUS SWITCH-> USING SMALL FOCUS INSTEAD) ON SITE AND THE DISPLAY LAYOUTS WERE SYNCHRONIZED TO THE OTHER ARTIS Q BIPLANE SYSTEM (COMPARATION SYSTEM ABOVE). NO SYSTEM MALFUNCTION OR SYSTEM DEFICIENCY CAN BE CONNECTED TO THIS IMAGE QUALITY ISSUE. NO HAZARD OR HAZARDOUS SITUATION HAD BEEN IDENTIFIED. THE INCIDENT DESCRIBED IN THE COMPLAINT IS NOT CLASSIFIED AS A REPORTABLE EVENT AFTER A THOROUGH INVESTIGATION AS NEITHER SERIOUS INJURY, DEATH, NOR UNEXPECTED PROLONGED HOSPITALIZATION OF THE PATIENT OR OTHER PERSON OCCURRED OR IS TO 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 AN IMAGE QUALITY PROBLEM WITH THE SYSTEM. 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
    1285740 ARTIS Q BIPLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10848282

    Patients

    Seq Age Sex Outcome Treatment
    1