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

Model Number	10308192
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
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 fusion system.The user reported that after the patient was given anesthesia, the system did not start up.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.The root cause was determined to be a hardware error.The uninterruptible power supply (ups) of the image pc failed due to a defective battery.As a result, the computer could not boot, and an on-site service intervention was necessary.Although the battery pack is a spare/consumable part, the on-site technician decided to replace the entire ups (ups 5p 850i) as a precaution.Examination of the returned part confirmed the suspected defect of the battery pack.The spare parts consumption of the affected component was checked and no increased consumption was found.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 FUSION
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11164632
• Report Number: 3004977335-2021-61515
• Device Sequence Number: 17045730
• Product Code: OWB
• UDI-Device Identifier: 04056869009056
• UDI-Public: 04056869009056
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1