MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH CIOS ALPHA VA30; 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	10/24/2023
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
Siemens became aware of a malfunction that occurred while operating the cios alpha va30 system.During an interventional procedure, no x-ray exposure was available.The patient had to be moved, and the procedure was completed on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The conducted investigation showed that the power components within the system were not disturbed.The d55 board was replaced as a precaution, and the system was brought back to specifications.Siemens local service engineer followed up with the customer a week after the occurrence and confirmed that no reoccurrence of the phenomenon was observed an extensive investigation could not be performed as the d55 board had not been returned for a detailed analysis.The root cause of the reported incident could not be determined.According to system experts, the d55 board had a malfunction which prevented distribution of power to the main unit of the system.The spare parts consumption of the defective power supply was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined by the investigation.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.
Additional Manufacturer Narrative
7/18/2024: supplemental mdr 2 was submitted to the fda for correction of the primary udi number in section d4.

• Brand Name: CIOS ALPHA VA30
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 18091898
• Report Number: 3004977335-2023-00146
• Device Sequence Number: 12233387
• Product Code: OWB
• UDI-Device Identifier: 04056869153490
• UDI-Public: (01)04056869153490(21)43222
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K210055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2024

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 12/11/2023; 07/18/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/11/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown