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

Model Number	10848282
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis q biplane system.The user reported that during an emergency procedure, x-ray could not be released.The procedure was continued and completed on 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 conduct an investigation of the reported event.
Additional Manufacturer Narrative
The investigation was completed by our experts by reviewing service reports, system history, and system log files.According to the log file analysis, a communication error happened between the digital image pre-processing (dipp) and real time controller (rtc) in plane a.The dipp could not boot correctly and was continuously reset.The system switched to the bypass mode and, therefore, the x-ray functionality was not available in plane b either.During onsite troubleshooting, siemens local service engineer found a problem with the real time controller (rtc) in plane a.The engineer performed the replacement of the rtc plane a, re-booted the system and tested functionality.The reported issue was resolved.The exchanged part was investigated; however, the detailed investigation of the exchanged part did not reveal any defect.Therefore, according to the expert opinion, the most likely cause of the reported issue was a contact problem, which was resolved with the exchange of the rtc.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.Section h6 g07001 ¿ real time controller.

• Brand Name: ARTIS Q BIPLANE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1; 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 liverty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 20394993
• Report Number: 3004977335-2024-00118
• Device Sequence Number: 20474602
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: (01)04056869009995
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181407
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 10848282
• Device Catalogue Number: 10848282
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 03/11/2025
• 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