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

Model Number	10848281
Medical Device Problem Code	Intermittent Continuity (1121)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens healthineers on (b)(6) 2025 that a malfunction occurred while operating the artis q ceiling.A patient with a myocardial infarction was admitted to the catheterization lab for surgery.After the equipment was turned on, the large screen in the catheterization lab showed no signal, preventing the doctor from performing the catheter placement procedure.The operator immediately called siemens healthineers customer service hotline who directed the customer to unplug and plug the signal cable at the back of the main unit.After restarting, the device returned to normal.The entire process took approximately 20 minutes, which delayed the patient's surgery to some extent.After the device was restored, the surgery proceeded smoothly, and the patient recovered well post-surgery.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens healthineers 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.
Additional Manufacturer Narrative
The investigation of the reported event was completed with the following results.Analysis of the system log files confirmed that the device remained in normal operational mode throughout the event, although the live video signal on the exam room monitor was unstable, preventing the physician from performing the catheter placement procedure.Siemens local service/tech support was contacted and responded promptly, providing instructions on how to reseat the dvi-dp male / dvi-i female (digital visual interface¿displayport male / digital visual interface¿integrated female) adapter and restart the system.Following these actions, full system functionality was restored within approximately 20 minutes.Further analysis identified improper seating of the dvi-dp male / dvi-i female adapter between the image acquisition system (ias) live output and the dvi cable connected to the exam room monitor as the root cause of the issue.No component failure was identified, and no parts were replaced.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 Q CEILING
• 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: 23802018
• Report Number: 3004977335-2025-00144
• Device Sequence Number: 9360456
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: (01)04056869009988
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 10848281
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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