MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG CIOS CONNECT; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number	10308193
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the cios connect system.During an intervention patient procedure, no x-ray exposure was possible.The patient was relocated to another hospital for further medical treatment.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.
Additional Manufacturer Narrative
The investigation of the reported issue was completed by our experts.Additional information has been provided stating that the system was returned back to operational state following replacement of the pc board by a third party.The customer did not request support from siemens healthineers service organization, therefore, information available for investigation is limited.The communicated error message indicates a problem with the x-ray control system (xcs) but could not be specified with the available information.Errors with the xcs can occur due to various causes.Without a detailed investigation of the replaced pc board, the root cause of the issue could not be determined.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.

• Brand Name: CIOS CONNECT
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: 22938449
• Report Number: 3004977335-2025-00106
• Device Sequence Number: 18621830
• Product Code: OXO
• UDI-Device Identifier: 04056869009049
• UDI-Public: (01)04056869009049
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153147
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: 10308193
• 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: 08/21/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 11/05/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown