BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTIS ZEE FLOOR

    MDR report key: 17200172 · Received June 26, 2023

    Report

    Report Number
    3004977335-2023-00049
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    June 8, 2023
    Report Date
    August 2, 2023
    Manufacturer
    SIEMENS HEALTHCARE GMBH
    Product Code
    OWB
    PMA / PMN Number
    K181407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION WAS PERFORMED ON EXPERT DISCUSSIONS (CONSIDERING COMPLAINT DESCRIPTION, CS REPORTS AND SYSTEM LOG FILES). ACCORDING TO THE PROVIDED INFORMATION, AFTER AN INTERVENTIONAL PROCEDURE, WHILE TRANSFERRING THE PATIENT FROM THE SYSTEM TABLE TO THE PATIENT BED, THE TRANSFER BOARD ACCIDENTLY PRESSED AND PUSHED THE JOYSTICK ON THE STAND CONTROL MODULE (SCM) AND CAUSED THEREBY AN UNINTENDED C-ARM MOVEMENT. THE MOVEMENT OF THE C-ARM HIT AN INFUSION STAND AND THE FLAT DETECTOR (FD) HIT THE PATIENT'S TRANSFER BED. AS A RESULT, THE PROXIMITY SWITCH (SAFETY FUNCTION) OF THE FD WAS ACTIVATED AND THE MOVEMENT WAS STOPPED. THE SAFETY FUNCTION WORKED AS INTENDED IN THIS ERROR SCENARIO. NO HEALTH CONSEQUENCES WERE REPORTED. THE ONSITE SERVICE INTERVENTION SHOWED NO MALFUNCTION OF THE C-ARM (E.G., SAFETY CONTACTS AND DMG OF THE JOYSTICK) CAUSING THE UNINTENDED SYSTEM MOVEMENT. SYSTEM WORKED AS SPECIFIED. HOWEVER, DUE TO THE COLLISION, THE COLLIMATOR AND FD WERE MISALIGNED, WHICH WAS CORRECTED AS PART OF THE SERVICE ACTIVITIES. TO PREVENT UNINTENDED SYSTEM MOVEMENTS, E.G., WHILE PATIENT TRANSFER, THE CONTROL MODULES SHALL BE DEACTIVATED BY PUSHING BUTTON ¿BLOCK MOVEMENT¿ OR BY TEMPORARILY REMOVING THE CONTROL MODULES. THE SYSTEM INSTRUCTIONS FOR USE GIVES ADEQUATE GUIDANCE FOR SECURE PATIENT TRANSFER. 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. 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 AN INCIDENT THAT OCCURRED ON THE ARTIS ZEE FLOOR UNIT. WHEN THE PATIENT PROCEDURE WAS COMPLETED AND THE PATIENT WAS BEING TRANSFERRED FROM THE SYSTEM TABLE TO A PATIENT BED, THE USER UNINTENTIONALLY HIT THE MOVEMENT BUTTON. AS A RESULT, THE C-ARM CRUSHED AN INFUSION STAND AND HIT THE BED. 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
    1452889 ARTIS ZEE FLOOR INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB SIEMENS HEALTHCARE GMBH 10094135

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown