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

Model Number	10094137
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Detailed investigation of the reported issue revealed that during the procedure the dipp (digital image preprocessing) detected a failure and tried to reset itself.The system message ¿no xray, fd problem, sc¿ was displayed to the user.Consequently, x-ray release was not available as the dipp could not start up while trying to reset.All system movements were still available.Analysis of the log files revealed that viper (digital signal processor board)/copra (common processing architecture) might not have been correctly plugged into the pci (peripheral component interconnect) slot of the rtc (real time controller) motherboard.A bad connection between the dipp hw and rtc basics was determined as the most probable relevant root cause for the non-conformity.The boards inside the rtc were cleaned and reseated by siemens local service, which resolved the problem.
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 became aware of a malfunction that occurred while operating the artis zee ceiling system.While performing an emergency patient procedure, no x-ray exposure was possible.Additional information was provided that the procedure was continued and completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.

• Brand Name: ARTIS ZEE 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 liverty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 21124914
• Report Number: 3004977335-2025-00010
• Device Sequence Number: 18062223
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: (01)04056869010052
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: CHINA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 01/01/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/12/2025
• 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