MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH CIOS FUSION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10308192
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
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.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the cios fusion system.During an interventional procedure, the device suddenly automatically shut down and then restarted.Following the restart, the system could not enter the operating system.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.The reported event occurred in (b)(6).
Additional Manufacturer Narrative
Despite several attempts to collect requested information, the user has not provided the data.However, the concerned system is running on old software version (va20d).It is known that the customer refused or cancelled several software updates.The system is approved to update to version va20h (distributed via an update instruction ax078/20/p).It is strongly recommended to update current software to a higher version.A possible general error, which would require corrective action of the installed base, could not be identified by the investigation.

• Brand Name: CIOS FUSION
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 12870036
• Report Number: 3004977335-2021-05724
• Device Sequence Number: 13907639
• Product Code: OWB
• UDI-Device Identifier: 04056869009056
• UDI-Public: 04056869009056
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153244
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021

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: 10308192
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 12/23/2021
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/23/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown