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

Model Number	11327600
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis icono biplane system.During an emergency patient procedure, no table movement was not possible.Additional information was provided that the patient was relocated to a different medical facility for further medical treatment.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
The investigation was performed by considering complaint description, customer service reports, system history, and log file analysis.Initial information received that during an emergency procedure, the table movement was not possible.The detailed log file analysis showed that the first time the control module cannot be reached was in the afternoon.The system was shut down in the evening with the issue still present.The system was switched on again at night for the emergency procedure, but the error persisted.The detailed log file analysis also showed that the message ¿emergency stop error - activate and deactivate a functioning emergency stop to enable system movement.Call service¿ was displayed.This occurs when an operating module, such as the table control module (tcm) in this case, cannot be reached.The emergency stop located on this operating module is no longer present in the safety circuit.As a safety rule, all movements are stopped and blocked.According to the instructions for use, by activating and deactivating a functioning emergency stop button when the message is shown, system movement is possible again with reduced speed.This was performed about 30 minutes after switching on the system for the emergency procedure.Although system movement in slow speed were available and performed, the patient was relocated to a different hospital to continue the procedure.Investigation further showed that the cable of the tcm was defective.The cable of the tcm was replaced and the issue was resolved.The occurrence rate of the 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.No health consequence was communicated.

• Brand Name: ARTIS ICONO BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 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: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 21207958
• Report Number: 3004977335-2025-00012
• Device Sequence Number: 18160288
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: (01)04056869063317
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 01/18/2025
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 05/14/2025
• 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