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

Model Number	10094137
Medical Device Problem Codes	Radiation Output Problem (4026); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
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
It was reported to siemens that a malfunction occurred while operating the artis zee ceiling system.The user reported that during an emergency patient procedure, x-ray image was not available.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
The investigation was performed on discussions considering complaint description, customer service reports, system history, system log files, and complaint part analysis.During an unplanned emergency procedure, the imaging functionality of the system was unavailable due to no x-ray being possible.The error message ¿no xray, please wait¿ was displayed to the user.As a system reboot did not solve the problem, the procedure was performed using an alternative system.No health consequences were reported to this event.During service activity the common processing architecture pc board (copra board) was identified to be malfunctioning.The copra board was replaced, which resolved the problem.The log file investigation confirmed temporary communication errors of the copra board.The copra board is located inside the image acquisition system pc (ias pc) and is responsible for the digital image preprocessing.The identified copra board issue was solved by replacement of the copra board.However, the analysis of the replaced copra board did not show any failures.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.
Additional Manufacturer Narrative
The investigation was performed with discussions considering complaint description, customer service reports, system history, system log files, & complaint part analysis.During an unplanned emergency procedure, the imaging functionality of the system was unavailable due to no x-ray being possible.The error message ¿no xray, please wait¿ was displayed to the user.As a system reboot did not solve the problem, the procedure was performed using an alternative system.No health consequences were reported to this event.During service activity the common processing architecture pc board (copra board) was identified to be malfunctioning.The copra board was replaced, which resolved the problem.The log file investigation confirmed temporary communication errors of the copra board.The copra board is located inside the image acquisition system pc (ias pc) and is responsible for the digital image preprocessing.The identified copra board issue was solved by replacement of the copra board.However, the analysis of the replaced copra board did not show any failures.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 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: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 20189276
• Report Number: 3004977335-2024-00112
• Device Sequence Number: 6793059
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: (01)04056869010052
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

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
• Device Catalogue 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: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 12/13/2024; 12/16/2024
• 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