MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT CIOS CONNECT; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10308193
Medical Device Problem Code	Operating System Becomes Nonfunctional (2996)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the cios connect system.During a procedure, the user reported that the c-arm stopped working.The failure caused the operation to be suspended for more than one hour.We are unaware of any 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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.No further actions are to be taken as there is no negative awareness regarding the quality and performance of the system.The investigation was performed considering complaint description, cs reports, and system history.According to the available information the c-arm stopped working during an interventional procedure.As a result, the procedure was suspended for more than one hour until an engineer (3rd party) fixed the problem.Unfortunately, a more in-depth and verifiable analysis of the problem described was not possible.Our technical department was denied access to the system and the customer did not provide log files or other necessary information.The problem was fixed by a 3rd party service provider.In this context, such on-site interventions may only be carried out by persons authorized by siemens-healthineers.Due to the above circumstances, the problem described was evaluated based on the available data and according to expert opinion.A possible general error, which would require corrective action of the installed base could not be identified by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: CIOS CONNECT
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12758599
• Report Number: 3004977335-2021-02301
• Device Sequence Number: 19668855
• Product Code: OWB
• UDI-Device Identifier: 04056869009049
• UDI-Public: 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/01/2021
• 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
• Patient Sex: Unknown