BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III FLOOR

    MDR report key: 20179592 · Received September 10, 2024

    Report

    Report Number
    3004977335-2024-00111
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 6, 2024
    Report Date
    December 26, 2024
    Manufacturer
    SIEMENS AG
    Product Code
    OWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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.

    Additional Manufacturer Narrative · 0

    SIEMENS WAS UNABLE TO CONDUCT A THOROUGH INVESTIGATION OF THE REPORTED ISSUE AS SIEMENS LOCAL SERVICE HAD NOT BEEN INVOLVED AND THE CUSTOMER HAD NOT PROVIDED LOG FILES OR FURTHER NECESSARY INFORMATION. DUE TO THE ABOVE CIRCUMSTANCES, THE REPORTED ISSUE 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

    IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE ARTIS ZEE III FLOOR SYSTEM. THE USER REPORTED THAT DURING AN EMERGENCY PATIENT PROCEDURE, X-RAY COULD NOT BE RELEASED. 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
    2296849 ARTIS ZEE III FLOOR INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS AG 10502501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown