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

Model Number	10848281
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will submitted upon completion of the analysis.Section h6 g07002 - monitor.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q ceiling system.During an emergency patient procedure, the monitor stopped working.The patient was moved for the procedure to be continued on alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
As part of the investigation the log files have been checked, but no errors were identified.No recurrences have been reported by the user.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: 22479455
• Report Number: 3004977335-2025-00082
• Device Sequence Number: 15464066
• Product Code: OWB
• UDI-Device Identifier: 04056869009988
• UDI-Public: (01)04056869009988
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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
• 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: 07/05/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/27/2025
• 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