BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 19259968 · Received May 7, 2024

    Report

    Report Number
    3004977335-2024-00049
    Event Type
    Malfunction
    Date Received
    May 7, 2024
    Date of Event
    April 25, 2024
    Report Date
    August 23, 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

    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 IS CONDUCTING A THOROUGH INVESTIGATION OF THE ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE REPORTED EVENT WAS COMPLETED. THE DETAILED LOG FILE ANALYSIS SHOWED ERROR MESSAGES WITHIN THE LOGS THAT INDICATED A FILAMENT FAILURE OF THE SMALL FOCUS WHICH LED TO FREQUENT BUT NOT PERSISTENT ABORTION OF X-RAY RELEASE. THIS MEANS THAT WHILE IMAGING USING THE SMALL FOCUS WAS HEAVILY DISTURBED, THERE WAS NO AUTOMATIC SWITCHOVER TO ANOTHER FOCUS INITIATED. THE AFFECTED X-RAY TUBE WAS REPLACED AS PART OF SERVICE ACTIVITY, WHICH RESOLVED THE PROBLEM. THE REPLACED X-RAY TUBE WAS INVESTIGATED, AND IT WAS CONFIRMED THAT THE SMALL FOCUS WAS DEFECTIVE. THEREFORE, A DEFECTIVE X-RAY TUBE SMALL FOCUS WAS IDENTIFIED AS A ROOT CAUSE OF THE ISSUE. THE OCCURRENCE RATE OF THE 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. THE INCIDENT DESCRIBED IN THE ADVERSE EVENT IS NOT CLASSIFIED AS A REPORTABLE EVENT AFTER A THOROUGH INVESTIGATION BECAUSE NEITHER SERIOUS INJURY, DEATH, NOR UNEXPECTED PROLONGED HOSPITALIZATION OF THE PATIENT OR OTHER PERSON OCCURRED OR IS TO BE EXPECTED, EVEN IF THE INCIDENT RECURS.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III CEILING SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, THE X-RAY RELEASE WAS BLOCKED. THE PROCEDURE WAS COMPLETED 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
    440549 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown