BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III FLOOR

    MDR report key: 19731727 · Received July 12, 2024

    Report

    Report Number
    3004977335-2024-00077
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 9, 2024
    Report Date
    August 13, 2024
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    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

    THE DEVICE LISTED IN SECTION D OF THIS REPORT IS NOT AN FDA 510(K) CLEARED MEDICAL DEVICE, BUT IS SIMILAR TO THE DEVICE WHICH IS CLEARED IN THE UNITED STATES WITH K181407. INVESTIGATION OF THE REPORTED EVENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    SIEMENS HAS ATTEMPTED AN INVESTIGATION OF THE EVENT. DURING SYSTEM START UP FOR AN EMERGENCY PROCEDURE, X-RAY RELEASE WAS NOT POSSIBLE WHICH LED TO A DELAY. SIEMENS WAS NOT CONTACTED TO TROUBLESHOOT NOR RESOLVE THE ISSUE. ACCORDING TO EXPERT OPINION, AFTER CONSIDERING THE AVAILABLE INFORMATION, THE ISSUE IS RELATED TO THE HARDWARE OF THE IMAGE ACQUISITION SYSTEM (IAS) PC. UNFORTUNATELY, IN THIS CASE, A MORE IN-DEPTH AND VERIFIABLE ANALYSIS OF THE PROBLEM DESCRIBED IN THE COMPLAINT WAS NOT POSSIBLE AS NEITHER A LOG FILE NOR OTHER NECESSARY INFORMATION IS AVAILABLE. ADDITIONALLY, NO INFORMATION WAS PROVIDED ON WHAT WAS DONE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III FLOOR SYSTEM. PRIOR TO AN EMERGENCY INTERVENTIONAL PROCEDURE, IT WAS DISCOVERED THAT THE SYSTEM WAS UNABLE TO RELEASE X-RAY PROPERLY, WHICH RESULTED IN A PROCEDURE DELAY. 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
    2301147 ARTIS ZEE III FLOOR INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown