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

Model Number	HITA869
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer reported on the 19th of december, 2024 that their aria server was not booting up, following a power outage on the (b)(6) 2024.System went down on (b)(6) 2023, this caused treatment delay for at least 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
Customer reported on the 19th of december, 2024 that their aria server was not booting up, following a power outage on the (b)(6) 2024.System went down on (b)(6) 2023, this caused treatment delay for at least 2 weeks.
Additional Manufacturer Narrative
The customer created new treatment plans for patients due to the extended treatment delay.They began treating patients again on the (b)(6) 2025.
Event or Problem Description
See completed (b)(4).

• Brand Name: ARIA RADIATION THERAPY MANAGEMENT
• Common Device Name: ARIA RADIATION THERAPY MANAGEMENT
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; täfernstrasse 7; daettwil 05405 ; SZ 05405
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 21168739
• Report Number: 3010123525-2025-00001
• Device Sequence Number: 18526282
• Product Code: IYE
• UDI-Device Identifier: 00856100006080
• UDI-Public: 00856100006080
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K133572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

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: HITA869
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 03/07/2025
• 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