MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS ARIA RADIATION THERAPY MANAGEMENT

Model Number	HIT8842
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer reported on the (b)(6) 2025 that their dell server suffered 3 disk failures.Their aria system is down as a result of the server failure.We are actively working with the customer to repair or replace the server.No malfunction or allegation against any varian product.Reporting is due to patients going without treatment for over 2 weeks.There is no claim of direct injury to any patient, but treatment interruption for greater than two weeks has the potential to decrease efficacy of radiation treatment.
Event or Problem Description
Aria down due to 3 disk failures on dell server.Customer has no service contract and the dell server is out of warranty.A local supplier visit was done, however the recommendations provided by the tech to repair the os were not possible even after multiple attempts.A disc replacement will be needed and is currently being sourced.Alternatively, a server replacement may be needed.
Additional Manufacturer Narrative
A new server was obtained and the customer confirmed completion of all service work by varian on the 16th of july 2025.They confirmed they had been treating patients since early may with a temporary solution and continue to treat successfully after all work completed with the permanent solution.
Event or Problem Description
See completed (b)(4) mfr 3010123525.

• Brand Name: ARIA RADIATION THERAPY MANAGEMENT
• Common Device Name: ARIA RADIATION THERAPY MANAGEMENT
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; täfernstrasse 7; daettwil
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 21313043
• Report Number: 3010123525-2025-00002
• Device Sequence Number: 20893996
• Product Code: IYE
• UDI-Device Identifier: 00856100006110
• UDI-Public: 00856100006110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HIT8842
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2025
• Supplement Date Received by Manufacturer: 01/12/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown