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

Model Number	10848283
Medical Device Problem Codes	Use of Device Problem (1670); Device Handling Problem (3265)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the reported event was performed by siemens experts based on complaint description, customer service reports, system history log files, and information provided by the user.The investigation confirmed that the system was fully functional at the time of the incident, and no technical issues or malfunctions were identified.According to the instructions for use, when moving the patient to the tabletop, the patient shall not be left unattended, the provided accessories shall be used, and the mattress shall always be kept fixed on the tabletop.As no further information was provided, the root cause could not be conclusively determined, however, a use-related issue cannot be excluded.No correction necessary as no system malfunction occurred.The occurrence rate of the identified use-related error pattern was reviewed.No accumulation of similar events or indication of a systematic product-related issue was identified.
Event or Problem Description
Siemens was informed about an adverse event that occurred while operating the artis q zeego system.The patient, who was placed on the table in the hybrid operating theatre, fell from the table.According to the information provided, the incident was described as an assisted fall or a slide.The patient later passed away; however, it was confirmed that the fall did not contribute to the death.No causal relationship between device performance and the patient¿s death was identified.

• Brand Name: ARTIS Q ZEEGO
• 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: 25043552
• Report Number: 3004977335-2026-00074
• Device Sequence Number: 21446968
• Product Code: OWB
• UDI-Device Identifier: 04056869010007
• UDI-Public: (01)04056869010007
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 10848283
• 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: 04/17/2026
• Initial Report FDA Received Date: 04/30/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown