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

Model Number	11105200
Medical Device Problem Code	Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2021
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 system was busy and no fluoro was possible.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.Despite all efforts, the investigation could not clearly clarify what caused the system behavior described in the complaint.The customer was trapped in a kind of continuous loop by the software from which he initially could not get out.According to his own information, he was supposed to acknowledge a pop-up window, but this did not trigger any function regardless of whether he clicked the "accept" or "cancel" button.If the reset button was pushed, the situation would have been resolved.The service technician pressed the reset button of the trolley-unit which recovered the system functionality promptly.No spare parts were exchanged and the system is currently working as specified.The technical experts couldn't find the root cause of the problem, but a workaround is available.We recommend pushing the reset button in case of reoccurrence so the system functionality will recover immediately.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 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: 11192688
• Report Number: 3004977335-2021-63204
• Device Sequence Number: 17082729
• Product Code: OWB
• UDI-Device Identifier: 04056869153490
• UDI-Public: 04056869153490
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,user f
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 11105200
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1