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

Model Number	10848600
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
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
Siemens became aware of a malfunction that occurred while operating the artis one system.Small focus x-ray imaging was not possible during an emergency cardiology procedure.Patient was relocated and the procedure was successfully completed on an alternate unit.Siemens is unaware of any health consequences to the involved patient.
Additional Manufacturer Narrative
Investigation of the provided log files was completed with the following results.The log dated (b)(6) 2024, showed that patient registration was done at 15:16:53, and x-ray release was performed at 15:51:28.After 12 fluoros and 2 acquisitions, multiple ax_pud 20502 events in the log indicated tube arcing that started at 15:58:53.At 15:59:57, ¿dose less than 5%¿ error was logged once.X-ray release was continued along with the above-mentioned errors.At 16:20:00 every x-ray with small focus was aborted with an error ¿dose less than 5%¿; tube current and dose were almost at 0.The system was powered off/on at 16:24:03/ 16:27:44.The user attempted 3 fluoros and 3 acquisitions but the issue for the x-ray release with small focus persisted.Siemens local service engineer inspected the unit the next day, and confirmed the issue was caused by the tube.The tube was replaced tube and the system was brought back to normal operation.The defective tube was returned for further analysis.A supplemental report will be submitted following tube investigation.
Additional Manufacturer Narrative
The defective tube was returned for further analysis.The investigation showed that the inductivity value of the large focus (f2) was in the range of the specification with 12.96 microhenries but the inductivity value of the small focus (f1) was not as expected with 13.9 microhenries.After disassembling the tube insert, it was confirmed that the small emitter (f1) was touching the focal head.Additionally, it was determined that the focal track was overloaded.Since the operation time of this x-ray tube assembly (xta) was twenty months with a load value of 37489 lu, an emitter wear-out is considered too short and it is not within the normal range of the expected lifetime.According to supplier analysis, no systematic issue are identified at this point of time and no further actions are required.

• 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 19164465
• Report Number: 3004754211-2024-00002
• Device Sequence Number: 12749845
• Product Code: OWB
• UDI-Device Identifier: 04056869009964
• UDI-Public: 04056869009964
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/18/2024

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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 06/18/2024
• Initial Report FDA Received Date: 04/23/2024
• Supplement Report FDA Received Date: 06/04/2024; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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