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

Model Number	10308192
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
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.The user reported that the foot switch stopped functioning during a function test.The procedure was continued and finished using an alternate 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
The investigation of the reported event was completed with the following results.According to the customer statement, during a function system test the footswitch was not working, thus, x-ray release with the footswitch was no longer available.However, the system can be operated without the foot switch as x-ray can be released with the hand switch.The operator manual contains instructions about the hand switch and how to operate it.Instructions of the physical functionality are provided with the system in the operator manual (chapter 1): subchapter: 1.1.4 physical functionality "the system is equipped with a footswitch and a hand switch for the release of radiation." in addition, chapter: 3 system description subchapter: 3.2.4 operating the hand switch unfortunately, it was not possible to conduct a more comprehensive investigation as no appropriate log files could be provided for the purpose of investigation.Furthermore, in the meantime, the situation has been rectified at the site.Following the hardware replacement, no further issues have been reported and the system works as intended.

• 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
• MDR Report Key: 12188865
• Report Number: 3004977335-2021-87115
• Device Sequence Number: 11640041
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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
• Initial Date Received by Manufacturer: 06/29/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 07/19/2021
• Supplement Report FDA Received Date: 08/30/2021
• 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