BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q ZEEGO

    MDR report key: 16378110 · Received February 15, 2023

    Report

    Report Number
    3004977335-2023-61641
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    December 20, 2020
    Report Date
    February 15, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH-AT
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS SUBMITTED ON FEBRUARY 15, 2023, DUE TO THE MANUFACTURER RECEIVING CLARIFICATION THAT MDRS ARE REQUIRED FOR SIMILAR DEVICE MARKETED BY THE MANUFACTURER, EVEN IF IT IS NOT 510(K) CLEARED OR IMPORTED TO THE UNITED STATES. THIS DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE BUT IS SIMILAR TO BRAND NAME OF THE USA CLEARED DEVICE WHOSE 510(K) NUMBER IS K181407. SIEMENS SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO INSPECT THE CONCERNED SYSTEM. THE ENGINEER DISCOVERED THAT THE REPORTED ERROR WAS CAUSED BY A FAILURE OF THE BIOS BATTERY ON THE KUKA CONTROL PC. THE BATTERY HAD A LOW CHARGE (0.8 V) RESULTING IN THE PC NOT ABLE TO BOOT UP. THE BATTERY WAS REPLACED, AND THE UNIT WAS BROUGHT BACK TO SPECIFICATIONS. TO REDUCE THE PROBABILITY OF A STARTUP PROBLEM DUE TO AN EMPTY BIOS BATTERY, SIEMENS RELEASED A FIELD CORRECTION VIA AN UPDATE INSTRUCTIONS AX073/21/S AND AX072/21/S IN MAY 2022. THE CORRECTIVE ACTION WAS REPORTED TO FDA UNDER C&R # 2240869-05/24/2022-0011-C (RES# 90407, Z-1343-2022). THE BIOS BATTERY HAD TO BE REPLACED, AND THE SERVICE INTERVAL WAS SHORTENED TO TWO YEARS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS Q ZEEGO SYSTEM. DURING AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR STENT IMPLANTATION, AN ERROR "COLLISION CONTORL DEACTIVATED" WAS DISPLAYED TO THE USER DURING SYSTEM BOOT UP. DUE TO A 30-MINUTE DELAY, THE PATIENT WAS MOVED TO AN ALTERNATE UNIT. THE CLINICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. SIEMENS IS NOT AWARE OF ANY ADVERSE IMPACT TO THE HEALTH OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927841 ARTIS Q ZEEGO IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH-AT 10848460

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown