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

Model Number	10849000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/30/2025
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 was informed on (b)(6) 2025 by its service organization that a malfunction occurred while operating the artis pheno.The display ceiling suspension (dcs) detached from the ceiling mounting.The issue happened before the scheduled procedure and caused the procedure to be canceled.We have no indications of any adverse effects on the health status of the involved patient or other persons.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
The investigation of the reported issue was completed by siemens experts.The investigation revealed that the interface plate (which connects the dcs to the ceiling substructure) was not installed correctly.During installation, the metal washers were omitted, and only plastic washers were used.These plastic washers were not suitable for the load-bearing requirements and could not support the weight of the dcs system.Consequently, the interface plate slipped through the installed screws, causing the dcs to detach.The suspension cables limited the fall, preventing the unit from reaching the floor.A new pivot large display (lg) was installed on the ceiling structure using bolts and correct metal washers.All systems in japan with similar installation conditions were checked.No other systems with this fault were identified.The cause is therefore be traced back to improper workmanship as a singular case.The occurrence rate of the identified cause has been checked, and no error accumulation has been identified.The occurrence rate is below the defined threshold.

• Brand Name: ARTIS PHENO
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 - or -; rittigfeld 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: 22685610
• Report Number: 3004977335-2025-00092
• Device Sequence Number: 18557668
• Product Code: OWB
• UDI-Device Identifier: 04056869046877
• UDI-Public: (01)04056869046877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K241572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2025

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: 10849000
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown