BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEEGO III (CHINA)

    MDR report key: 18392436 · Received December 26, 2023

    Report

    Report Number
    3004977335-2023-00166
    Event Type
    Malfunction
    Date Received
    December 26, 2023
    Date of Event
    December 5, 2023
    Report Date
    March 6, 2024
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS SUBMITTED AS MDRS ARE REQUIRED FOR SIMILAR DEVICES MARKETED BY THE MANUFACTURER, EVEN IF IT IS NOT 510(K) CLEARED OR IMPORTED TO THE UNITED STATES. THE DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE, BUT IS SIMILAR TO THE ARTIS ZEEGO DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407. THE 510K NUMBER WAS DELETED FROM THE SECTION G4. THIS MDR IS SUBMITTED AS MDRS ARE REQUIRED FOR SIMILAR DEVICES MARKETED BY THE MANUFACTURER, EVEN IF IT IS NOT 510(K) CLEARED OR IMPORTED TO THE UNITED STATES. THE DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE, BUT IS SIMILAR TO THE ARTIS ZEEGO DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY OUR EXPERTS. THE INSPECTION REVEALED THAT THE LEAD GLASS WAS CONNECTED TO THE ARM HOLDER WITH A BALL JOINT. BASED ON THE PROVIDED IMAGE, THIS CONNECTION FAILED. THE BALL WAS HELD BY A POLYETHYLENE PART INSIDE A FLANGE. IF THE LEAD GLASS IS TILTED WITH FORCE, DUE TO THE LEVERAGE HIGH TENSION APPLIED TO THE JOINT THE BALL CAN BE PUSHED OUT OF THE FLANGE. THE INSTALLATION AND USER MANUAL CONTAINS INFORMATION ON THE CORRECT MOVEMENT OF THE LEAD GLASS IN THE ¿OPERATION¿ CHAPTER; THE SUBCHAPTER ¿MOVING THE SHIELD¿ STATES: ¿TO MOVE THE SYSTEM, ALWAYS HOLD IT BY THE HANDLE PROVIDED OR BY THE METAL ROD.¿ SINCE THE X-RAY RELEASE AND THE MOVEMENT OF THE C-ARM ARE NOT AFFECTED, THE PROCEDURE COULD BE CONTINUED OR STOPPED IN A CONTROLLED MANNER IF REQUIRED. IN THE REPORTED CASE, THE PROCEDURE WAS CONTINUED ON THE IMPERFECT SYSTEM. WE HAVE NO INDICATIONS OF ADVERSE EFFECTS ON THE HEALTH STATUS OF PATIENTS, USERS OR THIRD PARTIES. A PUSHED OUT OF THE JOINT BALL DURING AN ATTEMPT TO TILT THE LEAD GLASS WITH FORCE WAS DETERMINED TO BE THE ROOT CAUSE OF THE INCIDENT. THE UPPER BODY RADIATION PROTECTION WAS REASSEMBLED BY THE CUSTOMER TO RESOLVE THE ISSUE. ADDITIONALLY, THE USER WAS PROVIDED A RECOMMENDATION TO EXCHANGE THE AFFECTED UPPER BODY RADIATION PROTECTION BY A TRAINED SIEMENS ENGINEER TO AVOID RE-OCCURRENCE. 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.

    Additional Manufacturer Narrative · 0

    H3, H6: SIEMENS HEALTHINEERS HAS INITIATED A DETAILED INVESTIGATION OF THE COMPLAINT EVENT AND SYSTEM. A SUPPLEMENTAL REPORT IF ADDITIONAL INFORMATION IS OBTAINED UPON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS HEALTHINEERS WAS INFORMED BY ITS SERVICE ORGANIZATION REGARDING AN EVENT ASSOCIATED WITH THE ARTIS ZEEGO III SYSTEM. IT WAS STATED THAT THE THAT DURING A PATIENT PROCEDURE, THE UPPER BODY RADIATION PROTECTION COMPONENT DROPPED ONTO THE PATIENT¿S HAND. ADDITIONAL INFORMATION WAS PROVIDED THAT ALTHOUGH THE ISSUE OCCURRED DURING THE PATIENT PROCEDURE, THE PROCEDURE WAS CONTINUED AND FINISHED USING THE IMPERFECT SYSTEM. NO SERIOUS INJURY TO THE PATIENT WAS COMMUNICATED. CLARIFICATION REGARDING THE DETAILS OF THIS EVENT HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED BY SIEMENS HEALTHINEERS AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530060 ARTIS ZEEGO III (CHINA) INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502505

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown