BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DBC

    MDR report key: 6968197 · Received October 23, 2017

    Report

    Report Number
    3004977335-2017-00538
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    October 13, 2017
    Report Date
    October 13, 2017
    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

    EXEMPTION NUMBER E2017017. (B)(4). 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. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM ARTIS DBC SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, IT WAS REPORTED THAT THE SYSTEM REVERTED TO A PERMANENT BLACK SCREEN. THE PATIENT WAS SAFELY REMOVED FROM THE SYSTEM AND TRANSFERRED TO AN ALTERNATE SYSTEM WHERE THE PROCEDURE WAS COMPLETED. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

    Additional Manufacturer Narrative · 1

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEFECTIVE COMPONENTS WERE NOT RETURNED TO SIEMENS FOR INVESTIGATION. THE COMPUTER PROCESSING THE IMAGES (BSR) FAILED TO BOOT UP DURING STARTUP. AS A RESULT, THE SYSTEM WENT INTO BYPASS FLUORO MODE WHERE CONTINUOUS FLUOROSCOPY IS AVAILABLE WITH REDUCED IMAGE QUALITY AND WITHOUT THE POSSIBILITY TO RECORD OR REVIEW ACQUIRED SCENES. THE USER ATTEMPTED TO RESTORE FULL SYSTEM FUNCTIONALITY BY RESTARTING THE COMPLETE SYSTEM WHICH WAS UNSUCCESSFUL. NO LOG FILES WERE AVAILABLE FOR INVESTIGATION AS THE EVENT OCCURRED DURING STARTUP OF THE SYSTEM. ACCORDING TO THE INFORMATION BY THE SERVICE ENGINEER (CSE), ALL SYSTEM MONITORS WERE DARK (BLACK DISPLAY) EXCEPT THE LIVE DISPLAY. THE CSE IDENTIFIED A DEFECTIVE BSR POWER SUPPLY WHICH LED TO THE DESCRIBED SYSTEM BEHAVIOR. FULL SYSTEM FUNCTIONALITY WAS RESTORED AFTER THE CSE REPLACED THE POWER SUPPLY OF THE BSR. THIS TYPE OF ISSUE IS OF RARE OCCURRENCE. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749029 AXIOM ARTIS DBC INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7728392

    Patients

    Seq Age Sex Outcome Treatment
    1