MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARCADIS VARIC GEN 2; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number	10143408
Medical Device Problem Codes	Use of Device Problem (1670); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of this event.The cause for the issue has not been determined yet.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
Siemens became aware of an incident that occurred with the arcadis avantic gen2 unit.No x-ray was available during an interventional procedure.The patient had to be moved and the exam was successfully completed on alternative system.There are no injuries attributed to this incident.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
Siemens has completed an investigation of the reported event.The investigation did not show a clear root cause for the reported error.The part which was exchanged on site and returned for investigation did not show any problem and works accordingly.Because the customer's database was rebuilt and the pc in question was replaced, i.E.The situation on site was changed and the problem was eliminated, a retrospective investigation that goes beyond the status achieved is no longer possible.Nevertheless, the error image indicates a temporary problem in the image chain communication.After a restart, the system has returned to its normal state.Our experts assume that this problem is due to a temporary poor contact between the respective components.As the potentially affected m460 pc was replaced and the error was no longer reported, it is assumed that the poor contact has been eliminated by the intervention on site.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: ARCADIS VARIC GEN 2
• Common Device Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10233212
• Report Number: 3004977335-2020-34964
• Device Sequence Number: 2426137
• Product Code: OWB
• UDI-Device Identifier: 04056869009001
• UDI-Public: 04056869009001
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K052202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: 10143408
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 09/04/2020
• Initial Report FDA Received Date: 07/06/2020
• Supplement Report FDA Received Date: 09/04/2020
• 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