BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 20830778 · Received December 3, 2024

    Report

    Report Number
    3004977335-2024-00140
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 29, 2024
    Report Date
    March 19, 2025
    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. THE INVESTIGATION WAS PERFORMED BY CONSIDERING COMPLAINT DESCRIPTION, CUSTOMER SERVICE REPORTS, SYSTEM HISTORY, SYSTEM LOG FILES, & COMPLAINT PART ANALYSIS. DURING AN EMERGENCY PROCEDURE, SYSTEM WAS NOT ABLE TO DO X-RAY RADIATION, CUSTOMER TRIED REBOOTING THE SYSTEM, BUT THE SYSTEM DID NOT RECOVER. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE SYSTEM. THERE WERE NO ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. THE CUSTOMER SERVICE ENGINEER (CSE) INVESTIGATED THE SYSTEM, ANALYZED LOG FILES AND PERFORMED TROUBLESHOOTING. LOGS INDICATED THAT ¿COLLIMATOR BLADE NOT MOVABLE¿, THIS RESTRICTED THE X-RAY FIELD VIEW THEREFORE NO X-RAY WERE POSSIBLE. CSE VERIFIED THE COLLIMATOR ERROR AND REPLACED THE COLLIMATOR, THIS FIXED THE ISSUE. THE DEFECTIVE COLLIMATOR WAS SENT BACK FOR DEEPER INVESTIGATION, DURING ANALYSIS IT WAS FOUND THAT THE D204 PRINTED CIRCUIT BOARD IN THE COLLIMATOR WAS DEFECTIVE, WHICH RESTRICTED THE COLLIMATOR MOVEMENT. THE RELEVANT ROOT CAUSE FOR THE NON-CONFORMITY WAS DETERMINED TO BE A DEFECTIVE COLLIMATOR. 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

    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 REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE III CEILING SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336958 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown