BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS Q.ZEN CEILING

    MDR report key: 22905583 · Received August 27, 2025

    Report

    Report Number
    3004977335-2025-00105
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    August 5, 2025
    Report Date
    October 8, 2025
    Manufacturer
    SIEMENS HEALTHINEERS AG
    Product Code
    OWB
    UDI-DI
    4056869010021
    PMA / PMN Number
    K181404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS CONDUCTED IN EXPERT DISCUSSIONS (CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS, SYSTEM HISTORY). THE INVESTIGATION DID NOT IDENTIFY SYSTEM FAILURE OR MALFUNCTION FOR THE TIME OF THE EVENT. IN GENERAL, TABLETOPS ALONE ARE NOT DESIGNED TO PREVENT A PATIENT FROM FALLING, IF NOT FIXED AS DESCRIBED IN THE INSTRUCTIONS FOR USE, DUE TO THE FLEXIBILITIES NEEDED FOR THE USER. APPROPRIATE MATERIAL IS PROVIDED WITH THE SYSTEM FOR PATIENT FIXATION. HOWEVER, FIXATION BY MEANS OF BELT/BODY STRAPS IS ESSENTIAL. THE PURPOSE OF THE BODY STRAPS IS TO PREVENT THE PATIENT FROM FALLING AFTER BEING TRANSFERRED TO THE TABLE. THE OPERATOR MANUAL CONTAINS ADEQUATE INSTRUCTIONS ABOUT PATIENT TRANSFER PROTOCOLS AND SAFETY MEASURES. RELEVANT WARNINGS ARE OUTLINED WITHIN THE CHAPTER TITLED "TRANSFERRING AND POSITIONING THE PATIENT." WARNING MOVEMENT OF THE PATIENT ON THE TABLETOP PATIENT MAY SLIP FROM THE TABLE TO THE GROUND. - NEVER LEAVE A PATIENT UNATTENDED ON THE TABLETOP. - USE THE PROVIDED ACCESSORIES, E.G. IMMOBILIZING STRAPS TO SECURE THE PATIENT IN A STABLE POSITION. - ALWAYS KEEP THE MATTRESS FIXED ON THE TABLETOP WITH THE VELCRO. WARNING PATIENT TRANSFER THE PATIENT MAY FALL TO THE GROUND. - MOVE SYSTEM INTO PATIENT TRANSFER POSITION. - PARK THE PATIENT STRETCHER/BED RIGHT ALONGSIDE THE PATIENT TABLE WITHOUT A GAP. - LOCK THE BRAKES OF PATIENT STRETCHER/BED. - ALWAYS KEEP THE MATTRESS FIXED ON THE TABLETOP WITH THE VELCRO. - PRESS THE BLOCK MOVEMENT BUTTON TO PREVENT MOTORIZED MOVEMENTS OR TEMPORARILY REMOVE THE CONSOLES. - PREVENT PUSHING THE TABLE TRANSVERSALLY WITH EXCESSIVE FORCE DURING PATIENT TRANSFER, OR HOLD IT IF IT CANNOT BE AVOIDED. - USE POSITIONING AIDS FOR MOVING THE PATIENT THE ENTIRE PROCESS OF PATIENT FIXATION AND TRANSFER IS UNDER THE RESPONSIBILITY OF THE OPERATOR. THAT INCLUDES THE TABLE TOP, THE MATTRESS, FIXATION ACCESSORIES, THE ALIGNMENT OF THE MATERIAL AND THE PATIENT ON THE TABLE AND A PROPER EXECUTION OR FIXATION PERFORMED BY THE OPERATOR INCLUDING SPENDING APPROPRIATE ATTENTION TO THE PATIENT, E.G. DEPENDING ON HIS RESPONSE ABILITY. AS RELEVANT ROOT-CAUSE FOR THIS INCIDENT AN INDIVIDUAL USE ISSUE WAS DETERMINED. THE PATIENT FELL OFF THE TABLE DURING THE TRANSFER AS THE PATIENT WAS NOT ADEQUATELY SECURED TO THE TABLE, AND THE OPERATOR HAS NOT RESPONDED QUICK ENOUGH TO PREVENT THE FALL. THE ARTIS Q.ZEN CEILING SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S FALL. THERE IS NO INDICATION OF A SYSTEM MALFUNCTION. 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

    SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. 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 Q.ZEN CEILING UNIT. DURING A PATIENT TRANSFER, THE PATIENT SLID OFF THE TABLE. DETAILED CLARIFICATIONS OF THIS EVENT ARE CURRENTLY ONGOING. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380636 ARTIS Q.ZEN CEILING INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHINEERS AG 10848354 4056869010021

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other