BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEEGO

    MDR report key: 8347110 · Received February 18, 2019

    Report

    Report Number
    3004977335-2019-67450
    Event Type
    Malfunction
    Date Received
    February 18, 2019
    Date of Event
    January 30, 2019
    Report Date
    January 30, 2019
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K141574
    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. (B)(4).

    Additional Manufacturer Narrative · 0

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE FAILURE. THE ANALYSES OF THE LOG FILES SHOWED THAT THE SYSTEM WAS POWERED UP AND BOOTED COMPLETELY READY. A NEW PATIENT WAS REGISTERED AND SEVERAL SUCCESSFUL FOOTSWITCH ACTIVITIES WITH X-RAY EXPOSURE WERE LISTED. LATER, A NETLINK (PART OF THE NETWORK) IS OBSERVED AS GOING DOWN AND THE SYSTEM ENTERS INTO BYPASS MODE. THIS DOES NOT REPRESENT A TOTAL LOSS OF FUNCTIONALITY OF THE SYSTEM AS CONTINUOUS FLUOROSCOPY WITH COMPROMISED IMAGE QUALITY IS AVAILABLE IN BYPASS FLUORO MODE. THE CUSTOMER PERFORMED A FEW QUICK FLUORO FOOTSWITCHES IN BYPASS MODE (PULSES GENERATED) AND SOON AN APPLICATION SHUTDOWN IS REGISTERED. DURING THE SYSTEM RE-BOOT ALL COMPONENTS REPORT READY EXCEPT THE IMAGE ACQUISITION SYSTEM (IAS) AND THE SYSTEM REMAINS IN BYPASS. THE CUSTOMER THEN RESTARTS THE SYSTEM AGAIN. THE SYSTEM BOOTS COMPLETELY READY AND THE CUSTOMER PERFORMED A COUPLE SUCCESSFUL FLUORO ACQUISITIONS, BUT ONCE AGAIN A NETLINK PROBLEM OCCURS A FEW MINUTES LATER AND THE SYSTEM ENTERS BYPASS MODUS. THE CUSTOMER INITIATES ANOTHER SHUTDOWN. NO FURTHER ATTEMPTS TO GENERATE X-RAY WERE REGISTERED IN THE LOG FILES. THE REMOTE SERVICE IDENTIFIED THAT THE IAS PC WAS UNRESPONSIVE. UPON INVESTIGATION THE CUSTOMER SERVICE ENGINEER REPLACED THE IAS. AFTER THE HARDWARE REPLACEMENT THERE WERE NO FURTHER ISSUES REPORTED. THE MANUFACTURER IS NOT CONSIDERING FURTHER ACTIONS RESULTING FROM THIS EVENT AS NO SYSTEMATIC ERROR HAS BEEN RECOGNIZED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEEGO SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT THE SYSTEM WENT DOWN AND THE PROCEDURE WAS STOPPED. 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
    140119 ARTIS ZEEGO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10280959

    Patients

    Seq Age Sex Outcome Treatment
    1