BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOM ARTIS BA

    MDR report key: 8703269 · Received June 17, 2019

    Report

    Report Number
    3004977335-2019-83107
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 23, 2019
    Report Date
    May 23, 2019
    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. ASSESSMENT DOES NOT INDICATE A SYSTEM FAILURE OR MALFUNCTION AND NO NON-CONFORMITY WAS IDENTIFIED. THE ANALYSIS OF THE LOG FILES SHOWED THAT DURING THE PROCEDURE THE IMAGE SYSTEM (BILD SYSTEM RECHNER (BSR)) FAILED INTERMITTENTLY. THE LOG FILES SHOW ABRUPT STOPPAGES WITHOUT ANY FURTHER LOGGING ACTIVITY WHICH WOULD HINT TOWARDS A POSSIBLE HARDWARE FAILURE. IT IS IDENTIFIED FROM SYSTEM-EVENT-LOGS THAT THE SCSI BUS DRIVER DETECTED A CONTROLLER ERROR AND THUS CAUSED THE BSR TO SHUT DOWN. WHEN THE BSR IS NOT AVAILABLE THE SYSTEM ENTERS "BYPASS FLUORO" MODE*. THE CUSTOMER PERFORMED A FULL SYSTEM SHUTDOWN MANUALLY AND REBOOTED WHICH RESOLVED THE PROBLEM AND FULL SYSTEM FUNCTIONALITY WAS RESTORED. NO PARTS HAD TO BE EXCHANGED. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT AS NO SYSTEMATIC ERROR HAS BEEN RECOGNIZED.

    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 BA SYSTEM. DURING AN EMERGENCY PROCEDURE, IT WAS REPORTED THAT THE SYSTEM SWITCHED OFF BY ITSELF RESULTING IN A DELAY IN PROCEDURE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON THE IMPERFECT 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
    496460 AXIOM ARTIS BA INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 5904656

    Patients

    Seq Age Sex Outcome Treatment
    1