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

Model Number	10308191
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
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 alpha system.During an interventional procedure, the user reported that the equipment suddenly stopped working.The procedure was continued and completed on 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.
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause could not be determined.Unfortunately, in this case, a more in-depth and verifiable analysis of the problem was not possible as our technical department was denied access to the system and the customer did not provide log files or other necessary information.In addition, the repair was not carried out by siemens healthineers, but by a third-party unknown to us.According to the customer, the system has already been repaired and is working.In this context, we would like to explicitly point out that such on-site interventions may only be carried out by persons authorized by siemens-healthineers.It should also be explicitly mentioned that the system is operated with the older software version va20b, and the customer repeatedly refused to install the required updates.The current version is va20g.Due to the above circumstances, the problem described in the complaint was evaluated based on the available data and according to expert opinion; a possible general fault - apart from the outdated software used on site - that would require corrective action of the installed base could not be identified by the investigation.

• Brand Name: CIOS ALPHA
• 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: 12306159
• Report Number: 3004977335-2021-92091
• Device Sequence Number: 14370145
• Product Code: OWB
• UDI-Device Identifier: 04056869009032
• UDI-Public: 04056869009032
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181560
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 10308191
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1