BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q ZEEGO

    MDR report key: 20891234 · Received December 10, 2024

    Report

    Report Number
    3004977335-2024-00145
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 11, 2024
    Report Date
    January 13, 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 INVESTIGATION WAS COMPLETED BY OUR EXPERTS. IN THE REPORTED CASE, THE CUSTOMER DID NOT ACCEPT AN ON-SITE SERVICE. BASED ON THE PROVIDED REPORT FROM THE MEDICAL FACILITY, DURING AN IN-HOUSE TROUBLESHOOTING SERVICE, IT WAS FOUND THAT THE FLAT DETECTOR (FD) POWER SUPPLY WAS DEFECTIVE. IN A CASE OF A FAILED POWER SUPPLY, THE COMMUNICATION TO THE FD WOULD BE LOST AND X-RAY RELEASE FUNCTIONALITY WOULD NOT BE AVAILABLE. BASED ON THE PROVIDED INFORMATION, THE ROOT CAUSE WAS DETERMINED AS A DEFECTIVE POWER SUPPLY FOR THE DETECTOR. THE PART WAS REPLACED, AND THE ISSUE WAS RESOLVED. A MORE IN-DEPTH AND VERIFIABLE ANALYSIS OF THE DESCRIBED ISSUE WAS NOT POSSIBLE AS NEITHER THE LOG FILES NOR OTHER NECESSARY INFORMATION WERE PROVIDED. 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 ZEEGO DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K123529. 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 Q ZEEGO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE SYSTEM REPORTED AN ERROR. AS A RESULT, THE PATIENT WAS RELOCATED TO ANOTHER CLINIC. 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
    1419285 ARTIS Q ZEEGO INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10848460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown