BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 22051640 · Received May 20, 2025

    Report

    Report Number
    3004977335-2025-00064
    Event Type
    Malfunction
    Date Received
    May 20, 2025
    Date of Event
    May 6, 2024
    Report Date
    June 17, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869012650
    PMA / PMN Number
    N/A
    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 DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE BUT IS SIMILAR TO ARTIS ZEE SYSTEMS WHOSE 510(K) NUMBER IS K181407. SIEMENS HEALTHINEERS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS COMPLETED BY OUR EXPERTS. IN THIS CASE, A MORE IN-DEPTH AND VERIFIABLE ANALYSIS OF THE REPORTED ISSUE WAS NOT POSSIBLE. SIEMENS LOCAL SERVICE WAS NOT INVOLVED IN THIS CASE, AND THE CUSTOMER DID NOT PROVIDE LOG FILES OR FURTHER INFORMATION NECESSARY FOR INVESTIGATION. THE SYSTEM WAS REPAIRED BY A THIRD-PARTY SERVICE PROVIDER WITHOUT SIEMENS INVOLVEMENT. NO INFORMATION WAS SHARED ABOUT THE REPAIR/SERVICE. THE EXACT ROOT CAUSE OF THE UNDERLYING PROBLEM COULD NOT BE DETERMINED. DUE TO THE ABOVE CIRCUMSTANCES, THE PROBLEM DESCRIBED IN THE COMPLAINT WAS EVALUATED ON THE BASIS OF THE AVAILABLE DATA AND EXPERT OPINION. A POSSIBLE GENERAL ERROR, WHICH WOULD REQUIRE CORRECTIVE ACTION OF THE INSTALLED BASE, COULD NOT BE IDENTIFIED BY THE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III CEILING. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT NO X-RAY WAS POSSIBLE. THE PATIENT WAS RELOCATED TO ANOTHER HOSPITAL AND THE PROCEDURE WAS CONTINUED THERE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191372 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502 04056869012650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown