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

Model Number	10094141
Medical Device Problem Codes	Poor Quality Image (1408); Insufficient Device Problem Information (3190); Radiation Output Problem (4026)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
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
Siemens became aware of a malfunction that occurred while operating the artis zee biplane system.While performing a fluoroscopy procedure on a patient, the obtained images were dark.Additional information was provided that the patient was relocated to a different medical facility due to this failure.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation was performed by considering complaint description, customer service reports, system history, & system log files.During the procedure, the customer was unable to do fluoro imaging on a biplane system (plane a and b) as expected.The small focus x-ray release failed repeatedly, though not continuously, and there was no automatic switch to the large or micro focus.Due to the issue customer decided to transfer the patient to another hospital to complete the procedure.There was no health issues reported as a result of this incident.Upon analyzing the log files, it indicated an error related to the small focus of the x-ray tube in plane 'a'.The system showed an error message ¿dose lower than 5% and high voltage remaining active after the pulse ended¿.Normally, the emitter has symmetrical distances to the boundary plates.If the distances are not symmetric it is probable that the emitter extends on thermal load and then may touch the focal boundary, which can cause various issues including arcing events.As a consequence, fluoro x-ray requests were aborted repeatedly though not continuously, thereby disrupting the fluoro imaging process.X-ray tube has three focal points.The issue was only with the plane ¿a¿ small focus, the small focus had not failed completely.Due to which the system did not automatically switch over to large focus.The user could do the switch over manually based on the organ protocol (ogp) in order to get the required image quality.If the small focus had failed completely, the system would have switched to the large focus automatically.Large focus was available for image acquisition based on the limited acquisition programs configured and to high thicknesses in case of acquisition programs configured for automatic focus switchover.This type of failure (focus failure with an intermittency preventing the activation of automatic error management mechanisms) has a rare occurrence.The issue was only in the plane a small focus, plane b was working as intended.Customer decided not to use the system.A customer service engineer (cse) was on site for troubleshooting, the customer was informed about the defective small focus.The organ protocols were adapted to use the large instead of the small focus.After troubleshooting, the system was restored to normal operation.The relevant root cause for the non-conformity was determined to be a defective x-ray tube of plane ¿a¿.Customer did not agree and chose not to replace the x-ray tube.A possible error accumulation or even a systematic error, which leads to a corrective action of the install base, could not be determined by the investigation.

• Brand Name: ARTIS ZEE BIPLANE
• 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: 21092694
• Report Number: 3004977335-2025-00008
• Device Sequence Number: 15612547
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: (01)04056869010069
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 10094141
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 04/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (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