MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10848600
Medical Device Problem Codes	Radiation Output Problem (4026); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.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.
Event or Problem Description
It was reported to siemens that a malfunction occurred while using the artis one.During an emergency procedure, the user reported that the small focus of the device did not emit radiation and the x-ray was aborted.The procedure was continued and finished using 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 investigate the reported event.
Additional Manufacturer Narrative
Analysis of the log files was performed to complete the investigation.The log showed that on (b)(6) 2025, patient registration was done at 07:29:43, and the x-ray release was performed at 07:33:39.According to the available x-ray data, after 7 radiation release attempts, at 07:35:11 the tube current was 0.This confirms the reported situation.Several more attempts were made to release the x-ray, but the issue with the small focus remained.Then system was powered off/ on at 07:37:21/ 07:41:53.After the unit was ready, two fluoro were released at 07:45 and both with the same 0 current.Remote service was initiated at 08:04:54.Siemens local service engineer inspected the system and confirmed that the issue was caused by a small focus in the tube.The tube was replaced, and the system was returned to normal operation.The defective tube was returned for further analysis.The report will be updated once the investigation result is available.
Additional Manufacturer Narrative
The returned tube was further analyzed.The investigation showed that during incoming inspection, the voltage value of the large focus was outside the specification, and it could be confirmed that the small focus was too close to the outer focal boundary and touched the focal head.An emitter failure is the typical cause for a tube to fail.The emitter and filaments are the typical wear parts and are limiting the lifetime of the tube.Considering the operation time of this x-ray tube of over five years with big load value, an emitter wear-out is considered in the normal range of the expected lifetime.No systematic issue is identified.No further actions are necessary at this point of time.

• Brand Name: ARTIS ONE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; 32 gaoxin c ave. 2nd; hi-tech industrial park; shenzhen 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD; 32 gaoxin c ave. 2nd; hi-tech industrial park; shenzhen 51805 7; CH 518057
• Manufacturer Contact: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 21216393
• Report Number: 3004754211-2025-00001
• Device Sequence Number: 3441988
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: (01)04056869009964
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2025

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: 10848600
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 04/25/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 03/10/2025; 04/25/2025
• 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