MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG ARTIS ICONO BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	11327600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis icono biplane.During an emergency procedure, the user reported that no movement was possible.The procedure was continued and finished using an alternate system.We have no indications of any adverse effects on the health status of the involved patient.Siemens healthineers has requested additional information in order to investigate the reported event.
Additional Manufacturer Narrative
Siemens healthineers is conducting a thorough investigation of the reported event.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
The investigation of the reported issue was completed by our experts by analyzing complaint description, cs (customer service) reports, system history, system log files).Log file analysis revealed that immediately after powering the system on, the following error messages appeared: ¿no collision detection.Reduced stand/table speed,¿ and ¿ neg.End switch active¿.These errors prevented any automatic system movements.Manual movement was also not possible as the machine was in park/transfer position.In this position (park/transfer) only automatic movement is allowed.Consequently, all system movement was disabled.Further log investigation showed that the system was moved manually (plane b transversal direction) while it was powered off.This caused both c-arms to enter a collision zone, which triggered safety mechanisms that blocked all movements.If manual movements are performed while the system is powered down, they alter the unit¿s positional data.As a result, the system detected a misalignment upon startup and automatically locked all motion.In such cases, the system requires readjustment before it can resume operation.The operator manual provides the following explains why manual movement is allowed when the system is powered off:.- rescuing the patient in an emergency e.G.In the event of a power failure, motorized system movements are not available.However, you can move parts of the system manually to ensure patient safety - moving artis icono biplane stands manually in case of system or power failure the top stand can be moved by pushing against the c-arm.- readjustment of the stand after moving the c-arm stand manually, while the system was not operating, the position calibration may be affected.In this case, system movements will be blocked, and the system must be readjusted.- call customer service.To resolve the issue, the customer performed the following steps: 1.Resolved the "collision between c-arms" error by manually rotating plane b to create sufficient clearance between plane b (collimator) and plane a, thereby unlocking the system movement.2.Activated system movement by pressing the dead man¿s grip (joystick a/b) or initiating the table lift, which moved plane b longitudinally and released the internal end switch.Once the end switch was released and no longer active, automatic drive functionality resumed.The system was successfully returned to the work area, and full functionality was restored.After troubleshooting system was brought to operational state, and the issue was fixed.The root cause of the incident was identified as user-related, specifically the manual movement of system components while the system was powered off.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.

• Brand Name: ARTIS ICONO BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 - or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 21908983
• Report Number: 3004977335-2025-00057
• Device Sequence Number: 8821547
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K241572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11327600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown