MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE BIPLANE; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10094141
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
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.Internal id #: (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.The user reported roadmap scenes not being clear during an emergency neurology procedure.The patient had to be moved, and the procedure was successfully completed on an alternate system.There is no report of 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.The reported event occurred in germany.
Additional Manufacturer Narrative
Siemens completed investigation of the reported issue."roadmap" is a special operating mode in which fluoroscopy images are subtracted from one another and displayed subtracted.During fluoroscopy, an image is inverted (mask) and superimposed over all subsequent fluoroscopy images.Roadmap makes catheter and guide wire positioning easier by emphasizing the vessels.To avoid any motion artifacts caused by changing the position between subtracted images, the patient should not move during the roadmap mode, nor should the patient table or system be moved.The on-site service intervention revealed that the patient table was slowly and continuously lowering due to a defective table lifting device.Therefore, the roadmap functionality should not have been used as the acquired live images would not match the vesslemap/mask resulting in bad image quality.The table lift assembly was replaced at the concerned site; the reported error was resolved and has not re-occurred since.Detailed investigation of the returned part revealed that a valve of the hydraulic lift was defective.As a result, the pressure inside the cylinder decreased continuously, causing the table to move slowly downward.The reported system was brought back to specifications.

• Brand Name: ARTIS ZEE BIPLANE
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 15824878
• Report Number: 3004977335-2022-52802
• Device Sequence Number: 6143404
• Product Code: OWB
• UDI-Device Identifier: 04056869010069
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 11/11/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 02/28/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown