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

Model Number	10094141
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
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.During an emergency patient procedure, the user was unable to move the stand to either a or b plane.The patient had to be moved and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens has completed an investigation of the event.The root cause was determined to be a hardware error.The investigation was performed considering complaint description, cs reports, system history, system log files, and complaint part analysis.During an emergency procedure system movement was possible only with reduced speed.The procedure was then performed using an alternative system.The onsite service intervention revealed a problem with the motor controller module (mcm) of plane b on a biplane system.As a result, the system could be moved with reduced speed only and system messages ¿reduced stand/table speed¿ and ¿collision control deactivated¿ were displayed to the user.To resolve the issue, the mcm was exchanged and detailed investigation of the defective part showed a failure of the low voltage power supply.The spare parts consumption of the defective power supply was checked.Any accumulation of faults or a possible general fault that would require corrective action of the installed base could not be determined.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• 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 HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 18630890
• Report Number: 3004977335-2024-00012
• Device Sequence Number: 18165841
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: 04056869010069
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/26/2024

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: 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: 01/23/2024
• Supplement Date Received by Manufacturer: 03/26/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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