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

Model Number	10848282
Medical Device Problem Code	Radiation Output Problem (4026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis q biplane system.During an emergency patient procedure, no x-ray was possible.The procedure was continued and successfully completed using an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplemental report will be submitted if additional information becomes available.Code 4755 - unknown component.
Additional Manufacturer Narrative
H3, h6: siemens healthineers completed the investigation of the reported issue.The investigation was performed on expert discussions (considering complaint description, cs reports, system history, system log files).During an emergency procedure, the system was unable to release x-rays, necessitating the use of an alternative system for the procedure.No health consequences were communicated to siemens healthineers because of the reported event.The system was investigated, and the logs were analyzed.The log evaluation identified an error with the rotating anode circuit (rac), indicating a malfunction in the anode rotation of the x-ray tube located in plane-a of the biplane system.Because the anode failed to rotate, the system automatically shifted to bypass mode, which also disabled x-ray imaging in plane-b.The issue was resolved by replacing the x-ray tube, after which the system worked as expected.The defective x-ray tube was sent back for further evaluation, where it was determined that a defective anode rotation drive had prevented the anode from starting its rotation.Investigations revealed that the cause of the non-rotating anode was a blocked anode bearing in the x-ray tube.Multiple potential reasons for the blocked anode bearing were examined, including foreign particles obstructing the bearing gap, overheating, and excessive vibration.Despite implementing measures designed to mitigate such failures in the past, the exact cause of the blocked anode bearing could not be determined retrospectively.To improve the overall product reliability and decrease the likelihood of similar issues occurring in the future, additional preventive measures have been put in place.These include improvements in bearing quality, as well as extensive testing for all delivered tubes to identify potentially compromised bearings.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.This complaint has been closed.

• Brand Name: ARTIS Q 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 20038573
• Report Number: 3004977335-2024-00103
• Device Sequence Number: 6405027
• Product Code: OWB
• UDI-Device Identifier: 04056869009995
• UDI-Public: (01)04056869009995
• Combination Product (Y/N): N
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2024

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: 10848282
• 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: 08/16/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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