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

Model Number	10848600
Medical Device Problem Codes	Positioning Problem (3009); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2025
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
Siemens became aware of a malfunction that occurred while operating the artis one system.Prior to an emergency patient procedure, it was discovered that system movements were blocked.The patient was relocated to a different medical facility to complete the procedure on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The log files have been analyzed.On feb 09, 2025, there was no patient registration, and the system was powered on at 12:07:34.During system startup, system detected abnormal fd off error at 12:07:40, which led to avs and mci reboot.During the reboot cycle, as expected, the system movement was not available.Before reboot cycle was completed, system was powered off/on at 12:12:15/12:17:03, another reboot cycle was initiated with limited system movement.System then detected aam_7 error and aam_1 error which could be possibly caused by either encoder hw defect or the mci missing reference position signal.Customer service engineer was onsite to check the system and found mci reference position was missing.Customer service engineer then restored the mci backup to recover the system.As above, the issue was assumed to be related to the loss of mci reference position signal.The accumulation of the same issue is not identified from the field.No further action is needed 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.; siemens mri center gaoxin c av; shenzhen 51805 7; CH 518057
• Manufacturer (Section G): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; siemens mri center gaoxin c av; shenzhen 51805 7; CH 518057
• Manufacturer Contact: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 21424060
• Report Number: 3004754211-2025-00002
• Device Sequence Number: 20778862
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 02/09/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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