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

Model Number	10094137
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis zee ceiling.During an emergency patient procedure, no x ray was possible.The patient had to be relocated to complete the procedure on an alternate system.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will submitted upon completion of analysis.
Additional Manufacturer Narrative
The investigation of the reported event was completed by our experts.The log analysis revealed that an oil pressure switch error occurred due to poor cable contact, which caused the oil pump to stop functioning.The system was used prior to the error, resulting in the x-ray tube to overheat.When the temperature exceeded the safety threshold, the system triggered a ¿no xray, tube too hot¿ message and automatically aborted the x-ray to prevent damage.During on-site troubleshooting, siemens customer service engineer (cse) cleaned and reseated the cables of the oil pump, which resolved the tube hot issue.The exact reason for the poor contact of the cables could not be determined retrospectively.During the service history analysis, it was found that the system was installed in august 2011 and had already completed its service life in june 2025.Considering the system's age, it could be possible that dust accumulated over time, and it may have contributed to the poor cable connection.The issue was resolved by cleaning and reseating the cable, with no parts replaced.The relevant root cause for the non-conformity was poor connection of the cables of oil pump at the x-ray tube.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.

• Brand Name: ARTIS ZEE CEILING
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; ritigfeld 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 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 22714540
• Report Number: 3004977335-2025-00093
• Device Sequence Number: 13044637
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: (01)04056869010052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 10094137
• 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: 07/29/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 08/12/2025
• 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