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

Model Number	10308194
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 spin system.During an interventional procedure on (b)(6) 2024, no x-ray was possible, and the issue led to a delay in the procedure.As of the date of this report, there is no indication of any adverse health effects to the involved patient.
Additional Manufacturer Narrative
The investigation was performed with discussions considering complaint description, customer service reports, system history, & system log files.During an interventional procedure, no x-ray was possible.To solve the problem, the user restarted the system and then continued the procedure.No health consequences were reported to this event.The system was investigated on site, but the root cause of the x-ray not possible issue could neither be determined nor reproduced.The issue has not occurred again since then.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.

• Brand Name: CIOS SPIN
• 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: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 20662782
• Report Number: 3004977335-2024-00133
• Device Sequence Number: 7305053
• Product Code: OWB
• UDI-Device Identifier: 04056869153506
• UDI-Public: (01)04056869153506
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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: 10308194
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 12/16/2024
• 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