BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 19342724 · Received May 17, 2024

    Report

    Report Number
    3004977335-2024-00053
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    May 9, 2024
    Report Date
    July 26, 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 INVESTIGATION OF THE REPORTED EVENT WAS COMPLETED. THE ONSITE SERVICE INTERVENTION SHOWED A DEFECTIVE POWER SUPPLY OF THE FLAT DETECTOR. THE EXCHANGE OF THE DEFECTIVE PART RESOLVED THE PROBLEM. 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. THE REPORTED DEVICE 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. NO PRIMARY UDI IN SECTION D4 IS REQUIRED.

    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 ZEE DEVICE WHICH IS CLEARED IN THE UNITED STATES UNDER K181407.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

    SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE III CEILING UNIT. THE ANGIOGRAPHY X-RAY UNIT USED TO PERFORM A CARDIOVASCULAR EXAMINATION AND INTERVENTIONAL PROCEDURE ON AN EMERGENCY PATIENT WOULD NOT REGISTER THE PATIENT¿S INFORMATION AFTER THE START-UP AND THE SYSTEM WAS NOT USABLE. THE UNIT WAS RE-STARTED SEVERAL TIMES WITH NO SUCCESS. AFTER A DELAY THE PATIENT WAS TRANSFERRED TO A DIFFERENT MEDICAL 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
    921716 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown