BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q ZEEGO (CHINA)

    MDR report key: 19286526 · Received May 10, 2024

    Report

    Report Number
    3004977335-2024-00052
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    May 1, 2024
    Report Date
    August 13, 2024
    Manufacturer
    SIEMENS HEALTHINEERS AG
    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

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE EVENT. THE INVESTIGATION WAS PERFORMED CONSIDERING COMPLAINT DESCRIPTION, CUSTOMER SERVICE REPORTS, SYSTEM HISTORY, LOG FILE ANALYSIS, AND CC-PART ANALYSIS. INVESTIGATION SHOWED THAT THE ANODE ROTATION DRIVE OF THE X-RAY TUBE WAS BLOCKED. WHY OR HOW THE ANODE ROTATION DRIVE WAS BLOCKED COULD NOT BE DETERMINED. FOLLOWING THE EXCHANGE OF THE X-RAY TUBE, THE SYSTEM WORKED AS INTENDED. THE OCCURRENCE RATE OF THE PATTERN WAS CHECKED. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH WOULD LEAD TO A CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE DETERMINED BY THE INVESTIGATION.

    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 Q ZEEGO DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407. SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS Q ZEEGO UNIT. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY COULD BE RELEASED. THE PROCEDURE HAD TO BE CONTINUED ON AN ALTERNATE UNIT. 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
    2308834 ARTIS Q ZEEGO (CHINA) INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10848460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown