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

Model Number	10848600
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be submitted if additional becomes available.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis one system.The system would not start up prior to the beginning of an unplanned emergency patient procedure.The patient was relocated to a different medical facility to complete the procedure.We are unaware of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation of the reported event has been completed.The investigation has been performed based on log files analysis, replaced parts investigation and expert opinion.Log file analysis: checked log on sep 08, 2025, the system was powered off at 15:33:08 and log stopped at 15:35:19.No log was available for the mentioned event time 23:34.This confirms that the system was not powered on at this time.Siemens local customer service engineer (cse) did an on-site system inspection and identified that the image system ups (uninterrupted power supply) had been disconnected and bypassed by the customer technical department following the issue occurrence, then the system could start up normally.The engineer preventively replaced the image system ups and its signal cable.The image system ups is a battery-backed system, which provides emergency power in the event of main power supply failure.It is located between the system cabinet (main power supply) and the image system.If the image system ups is defective or with cable connection issue, the system startup will be affected.The replaced parts have been returned for further investigation.No defect was found on the replaced image system ups and its signal cable.No other abnormalities were observed for the system.The root cause could not be identified retrospectively.Therefore, it is unclear why or how the failure occurred.According to our expert opinion, the likely cause was physical cable connection issue at the event time and reconnection done during the ups bypassing process performed by customer.The service part consumption rate of the image system ups and the signal cable are in low and within the acceptable level.The system has been monitored for almost two months without any similar issue observed.No further actions are determined at this point in time.

• Brand Name: ARTIS ONE
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri center gaoxin c av; shenzhen 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen 51805 7; CH 518057
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 23061931
• Report Number: 3004754211-2025-00003
• Device Sequence Number: 13213653
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: (01)04056869009964
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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