BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE III CEILING

    MDR report key: 17951176 · Received October 17, 2023

    Report

    Report Number
    3004977335-2023-00131
    Event Type
    Malfunction
    Date Received
    October 17, 2023
    Date of Event
    October 13, 2023
    Report Date
    February 5, 2024
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    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 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 ISSUE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAIBLE. H6 - C-ARM.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF THE REPORTED EVENT WAS COMPLETED. THE UNIT WAS INSPECTED BY A LOCAL SIEMENS CUSTOMER SERVICE ENGINEER (CSE). THE INVESTIGATION BY THE CSE REVEALED THAT THE C-ARM PROXIMITY SWITCH HAD SLIPPED OUT OF ITS MOUNTING FURROW AT THE END OF THE C-ARM. THIS RESULTED IN THE PROXIMITY SWITCH TO GET ACTIVATED BY LOWERING THE C-ARM TOO CLOSE TO THE FLOOR. THE SYSTEM MESSAGE ¿C-ARM PERIPH GUARD ACTIVE¿ WAS DISPLAYED TO THE USER. AFTER THE PROXIMITY SWITCH REINSERTED BACK INTO THE MOUNTING FURROW THE SYSTEM WORKED AS INTENDED AGAIN. THE ROOT CAUSE, WHY THE PROXIMITY SWITCH SLIPPED OUT OF ITS MOUNTING FURROW, COULD NOT BE DETERMINED RETROSPECTIVELY. IT IS ASSUMED THAT IMPROPER HANDLING OF THE SYSTEM RESULTED IN MECHANICAL IMPACT (E.G., COLLISION WITH UNKNOWN OBSTACLE). A POSSIBLE GENERAL ERROR THAT WOULD REQUIRE CORRECTIVE MEASURES OF THE INSTALLED BASE COULD NOT BE DETERMINED BY THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN INCIDENT OCCURRED WHILE OPERATING THE ARTIS ZEE III CEILING SYSTEM. ACCORDING TO THE USER, THE C-ARM HIT THE FLOOR AND COULD NOT BE MOVED DURING THE OPERATION. THE MACHINE RECOVERED FOLLOWING THE SYSTEM REBOOT. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077626 ARTIS ZEE III CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10502502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown