MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG CIOS FUSIONCIOS FUSION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10308192
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: the reporting facility contact name and phone number were not provided for reporting purposes.H3, h6: siemens healthineers has initiated a detailed investigation of the complaint event and system.A supplemental report will be submitted if additional information is obtained upon the completion of the investigation.
Event or Problem Description
Siemens healthineers was notified by its service organization of an issue with the cios fusion system.A black screen occurred during an emergency procedure, which was continued and finished using an alternative system.As of the date of this report, there are no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation of the reported event was completed by our experts.Siemens local service engineer checked the system functionality.During troubleshooting the engineer observed voltage fluctuation on the d55 printed circuit board.The d55 board was replaced, and the reported issue has not re-occurred.The log files were analyzed, but a conclusive root cause could not be determined as system automatically turned off.The cause of the complaint could not be determined retrospectively.Following the hardware replacement, there were no further issues, and the system works as intended.

• Brand Name: CIOS FUSIONCIOS FUSION
• 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: 20831172
• Report Number: 3004977335-2024-00141
• Device Sequence Number: 8638600
• Product Code: OWB
• UDI-Device Identifier: 04056869009056
• UDI-Public: (01)04056869009056
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

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: 10308192
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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