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

Model Number	10094141
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to siemens healthineers that a malfunction occurred while using the artis zee biplane.During an emergency procedure, the user stated that patient registration was not possible and that the large display was dark.The system was rebooted several times and still did not come to ready state.The procedure was continued and finished using an alternate system.We have no indications of any adverse effects on the health status of the involved patient.Siemens healthineers has requested additional information in order to investigate the reported event.
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 follow-up report will be filed upon completion of the investigation.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be a hardware error.Detailed investigation revealed that the power supply module for the mdm (multi display manager, large display controller) was defective.As a result, the system switched into bypass mode, as the large display went dark.There were additional displays available.Bypass mode describes the mode where only continuous fluoroscopy with reduced image quality is available, and the acquired scenes cannot be saved and reviewed.All system movements were still working as intended.The customer tried to solve the problem by performing a power cycle (system off/on) with no success.The defective power supply was exchanged as part of service activities and resolved the problem.A possible error accumulation or even a systematic error, which would lead to a corrective action of the installed 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: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 21633691
• Report Number: 3004977335-2025-00040
• Device Sequence Number: 9276727
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: (01)04056869010069
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

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: 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: 03/14/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 07/22/2025
• 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