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

Model Number	11327600
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the artis icono biplane system.During an emergency procedure, the system repeatedly went into bypass mode.The patient was moved to a different room 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 is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.
Additional Manufacturer Narrative
The investigation of the reported issue was completed by our experts.The onsite service inspection identified an issue with the large display.The large display was exchanged as part of service activity, which resolved the problem.Detailed investigation of the defective part revealed that the large display's backlight sensor module was defective, resulting in a decrease in luminance after 15 minutes of operation.Eventually, this caused the system to go into "bypass" mode.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.

• Brand Name: ARTIS ICONO 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: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18675886
• Report Number: 3004977335-2024-00017
• Device Sequence Number: 6194790
• Product Code: OWB
• UDI-Device Identifier: 04056869063317
• UDI-Public: 04056869063317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193326
• 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): 06/18/2024

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: 11327600
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 06/18/2024
• 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