BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DFC

    MDR report key: 11912148 · Received June 1, 2021

    Report

    Report Number
    3004977335-2021-82011
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 1, 2021
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE ERROR. UNFORTUNATELY, THE AFFECTED PART WAS NOT AVAILABLE FOR EXAMINATION AS THE HOSPITAL TECHNOLOGY DEPARTMENT REPLACED THE TOUCH SCREEN, I.E., THE EXAMINATION CONTROL CONSOLE (ECC), AND DID NOT MAKE IT AVAILABLE FOR EXAMINATION. THE INVESTIGATION IS BASED ON THE EXAMINATION OF THE LOG FILES AND THE RESULTING CONCLUSIONS OF THE TECHNICAL EXPERTS. AFTER A PROCEDURE, THE OPERATOR MANUALLY BLOCKED THE RADIATION FOR THE PURPOSE OF PENDING PATIENT TRANSFER. AT THE START OF THE NEXT EXAM, THE OPERATOR THEN ATTEMPTED TO RE-ENABLE THE RADIATION FUNCTIONALITY, BUT FOUND THAT THE TOUCH SCREEN (ECC) WAS NO LONGER RESPONSIVE TO TOUCH. ALTHOUGH THE ECC WAS NOT FUNCTIONING, ALL THE ECC FUNCTIONS (CONTROL OF X-RAY PARAMETERS, CONTROL OF SOME GENERAL SYSTEM SETTINGS LIKE MOVEMENT/RADIATION, IMAGE REVIEW AND POST-PROCESSING LIKE CALIBRATION) WERE STILL AVAILABLE ON THE SECOND OPERATOR SYSTEM, THE IMAGE VISUALIZATION SYSTEM (IVS) IN THE CONTROL ROOM. THE OPERATOR DECIDED TO PERFORM THE EXAMINATION ON A DIFFERENT SYSTEM. WHILE THE CAUSE OF THE ERROR CANNOT BE DETERMINED BEYOND DOUBT, THE TOUCHSCREEN WAS REPLACED BY THE CUSTOMER'S SYSTEM ENGINEER ON SITE. AFTER REPLACEMENT, THE SYSTEM AGAIN FUNCTIONED AS SPECIFIED. A POSSIBLE GENERAL ERROR THAT WOULD REQUIRE CORRECTIVE MEASURES OF THE INSTALLED BASE COULD NOT BE DETERMINED BY THE INVESTIGATION. 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 AXIOM ARTIS DFC SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED NO TOUCH REACTION ON THE EXAMINATION CONTROL CONSOLE (ECC) AND DISABLE X-RAY WAS NOT POSSIBLE. 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
    811218 AXIOM ARTIS DFC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7412807

    Patients

    Seq Age Sex Outcome Treatment
    1