BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR III

    MDR report key: 19547076 · Received June 17, 2024

    Report

    Report Number
    3004977335-2024-00065
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 29, 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 CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORT EVENT WAS COMPLETED. INFORMATION WAS PROVIDED THAT NO ALTERNATE SYSTEM WAS AVAILABLE AT THE CUSTOMER SITE, THEREFORE, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL TO COMPLETE THE PROCEDURE. NO ADVERSE HEALTH CONSEQUENCES WERE COMMUNICATED. THE INVESTIGATION SHOWED THAT THERE WAS A LOOSE CONTACT ON THE D600 BOARD, WHICH CAN ALSO BE OBSERVED IN THE ERROR LOGS RELATED TO POWER SUPPLY VOLTAGE ERROR. THE LOOSE CONTACT ON THE D600 BOARD WAS RECTIFIED AND RECONNECTED BY SERVICE ENGINEER DURING AN ON-SITE VISIT. THE POOR CONTACT ON THE D600 BOARD WAS IDENTIFIED A ROOT CAUSE OF THE EVENT. 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 IT 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 EVENTS. AS THIS EVENT IS UNDER INVESTIGATION, A ROOT CAUSE HAS NOT YET BEEN DETERMINED. A SUPPLEMENT REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III FLOOR SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY, FLUORO OR ACQUISITIONS WERE POSSIBLE. THE USER TRIED RESTARTING THE UNIT WITH NO SUCCESS. THE PATIENT WAS RELOCATED TO ANOTHER FACILITY TO COMPLETE THE PROCEDURE ON AN ALTERNATE UNIT. 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
    1332818 ARTIS ZEE FLOOR III INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502501

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown