BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS DTA

    MDR report key: 9580295 · Received January 13, 2020

    Report

    Report Number
    3004977335-2020-13026
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 23, 2019
    Report Date
    December 23, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K052202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE DEFECTIVE HARDWARE. THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS, SYSTEM HISTORY AND SYSTEM LOG FILES. THE INVESTIGATION OF LOG FILES SHOWED THAT THE SYSTEM BOOTED TO APPLICATION NORMALLY AND THE FAILURE IS OBSERVED DURING THE PROCEDURE. IT IS IDENTIFIED FROM LOGS THAT THE "RADIOGRAPHIC IMAGE SYSTEM" (BSR) FAILED ABRUPTLY DURING THE PROCEDURE AND ON-GOING FLUORO WAS ABORTED. IN THIS CASE THE SYSTEM GOES INTO BYPASS FLUORO MODE. THE CUSTOMER PERFORMED A HARDWARE POWER OFF AND REBOOTED THE SYSTEM, HOWEVER, THE SYSTEM DID NOT BOOT AT ALL. IF THE SYSTEM FAILS ABRUPTLY WITHOUT FURTHER LOGGING ACTIVITY, INDICATING A BSR HARDWARE FAILURE, THE COMPLETE SYSTEM GOES INTO BYPASS MODE. AN EXTENSIVE INVESTIGATION COULD NOT BE PERFORMED BECAUSE THE AFFECTED PART WAS NOT RETURNED. THE LOG FILES DO NOT SHOW MUCH INFORMATION TO FIND THE EXACT HARDWARE ERROR, HOWEVER, FROM EXPERIENCE AND EXPERT OPINION IT IS DETERMINED THAT DEFECTIVE BSR HARDWARE CAUSED THE PROBLEM. THE CUSTOMER SERVICE ENGINEER REPLACED THE BSR AND RETURNED THE SYSTEM TO NORMAL OPERATION. NO SERIOUS INJURY, DEATH, OR UNEXPECTED PROLONGED HOSPITALIZATION OF THE PATIENT OR OTHER PERSON HAS OCCURRED OR COULD BE EXPECTED IF THE PROBLEM REOCCURS.

    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 DTA SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THE IMAGE SYSTEM WAS DOWN. 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
    44141 AXIOM ARTIS DTA INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 7008605

    Patients

    Seq Age Sex Outcome Treatment
    1