BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE CEILING

    MDR report key: 21025561 · Received December 27, 2024

    Report

    Report Number
    3004977335-2024-00159
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 6, 2024
    Report Date
    January 28, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    04056869010052
    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

    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 FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    DETAILED INVESTIGATION OF THE REPORTED EVENT REVEALED THAT DURING THE PROCEDURE A PROXIMITY SWITCH ON THE OUTER SIDE OF THE C-ARM (C-ARM PERIPHERAL GUARD) BECAME ACTIVE. THE SYSTEM DISPLAYED THE FOLLOWING MESSAGES ¿LIMITED STAND/TABLE MOVEMENT, SC¿ AND ¿REDUCED STAND/TABLE SPEED, SC¿ TO THE USER. CONSEQUENTLY, NORMAL SYSTEM MOVEMENT (NORMAL SPEED, AUTO DRIVE) WERE RESTRICTED, AND SYSTEM MOVEMENT WAS ONLY AVAILABLE IN THE OVERRIDE MODE (¿OVERRIDE MODE¿ IS A MODE WHERE COLLISION PROTECTION IS DEACTIVATED, AND THE SYSTEM CAN ONLY BE MOVED MANUALLY AT SLOW SPEED). ANALYSIS OF THE LOG FILES REVEALED THAT THE SYSTEM WAS NOT USED IN THE OVERRIDE MODE AFTER THE PROXIMITY SWITCH BECAME ACTIVE. IT WAS DETERMINED THAT THE MALFUNCTION OF THE PROXIMITY SWITCH OF THE C-ARM WAS THE ROOT CAUSE OF THE ISSUE. THE PROXIMITY SWITCH OF THE C-ARM WAS REPLACED AS PART OF SERVICE ACTIVITY, WHICH RESOLVED THE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE ARTIS ZEE CEILING. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THEY RECEIVED AN ERROR MESSAGE, ¿PROXIMITY OR QS ERROR¿ WHICH CAUSED LIMITED STAND/TABLE MOVEMENT DURING 3D. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2191033 ARTIS ZEE CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10094137 04056869010052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown