BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 22096959 · Received May 28, 2025

    Report

    Report Number
    3004977335-2025-00070
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 16, 2025
    Report Date
    August 26, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869012650
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE BUT IS SIMILAR TO THE ARTIS ZEE DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407. SIEMENS HEALTHINEERS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY OUR EXPERTS BY CONSIDERING COMPLAINT DESCRIPTION AND REVIEWING SERVICE REPORTS, SYSTEM HISTORY, SYSTEM LOG FILES. DURING AN ON-SITE TROUBLESHOOTING, SIEMENS LOCAL CUSTOMER SERVICE ENGINEER (CSE) FOUND A PROBLEM WITH COBRA BOARD IN THE RTC. THE CSE REPLACED THE COBRA BOARD, AND THE ISSUE WAS RESOLVED FOLLOWING THE REPLACEMENT. THE EXCHANGED COBRA BOARD WAS RETURNED FOR ANALYSIS. SEVERAL DIAGNOSTIC TESTS WERE PERFORMED, INCLUDING MEMORY TESTS AND PCI DMA TESTS. THE INVESTIGATION RESULTS INDICATED THE ROOT CAUSE IS LIKELY RELATED TO PCI COMMUNICATION RESULTING IN SPORADIC FAILURE AT COBRA BOARD. HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED RETROSPECTIVELY. THE OCCURRENCE RATE OF THE AFOREMENTIONED ERROR PATTERN WAS CHECKED. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH LEADS TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE DETERMINED BY THE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING III SYSTEM. DURING AN EMERGENCY CORONARY ANGIOGRAPHY PROCEDURE, NO X-RAY EXPOSURE WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329271 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502 04056869012650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown