BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 19731670 · Received July 12, 2024

    Report

    Report Number
    3004977335-2024-00076
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    May 23, 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

    SIEMENS HAS COMPLETED AN INVESTIGATION OF THE EVENT. DURING AN EMERGENCY PROCEDURE, NO STAND MOVEMENT WAS POSSIBLE. SIEMENS WAS NOT CONTACTED TO TROUBLESHOOT NOR RESOLVE THE ISSUE. ACCORDING TO AVAILABLE INFORMATION, THE CUSTOMER REPLACED THE MOTOR CONTROLLER MODULE (MCM) OF THE STAND AND THE ISSUE WAS RESOLVED. THE REPLACED PART WAS NOT SENT BACK FOR FURTHER INVESTIGATION. THEREFORE, IT IS ASSUMED THAT THE ISSUE WAS CAUSED BY A DEFECTIVE MCM. THE OCCURRENCE RATE OF THE ERROR PATTERN WAS CHECKED. A POSSIBLE ERROR ACCUMULATION OR EVEN A SYSTEMATIC ERROR, WHICH WOULD LEAD 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 DEVICE CLEARED IN THE UNITED STATES WITH K181407. THE INVESTIGATION OF THE REPORTED EVENT IS ON-GOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED 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 SYSTEM. A PATIENT WITH ACUTE MYOCARDIAL INFARCTION WAS ADMITTED TO A MEDICAL FACILITY. DURING AN EMERGENCY INTERVENTIONAL PROCEDURE, THE C-ARM STAND MOVEMENTS WERE BLOCKED AND THE PATIENT HAD TO BE MOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED 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
    314233 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown