MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS ARIA RADIATION THERAPY MANAGEMENT; ARIA RTM (SOFTWARE MEDICAL DEVICE)

Model Number	HITA870
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The equipment was ordered from rhenus warehouse on dec 5.They were notified via email from warehouse (rhenus warehouse, switzerland), that equipment is ready - which was on the 11th dec 2023.On the same day they informed logistic partner that the equipment is ready for shipment.The dangerous nature of the goods and flight availability has caused the delay in shipping, and first available flight was on 21st dec with the final date of delivery 23rd of december.The flight was then again delayed with proposed date of delivery 27 dec 2023.
Event or Problem Description
Aria server and backup tape drive suffered water damage and are defective.It was seen condensation inside the small lcd screen of the server's front panel, server was disconnected.It was noticed, that in cd drive, ssds and tape backups was water inside as well.From the physical inspection of the server, it was concluded that it had short circuited due to moisture from the faulty ac unit and is unrecoverable, and the site would therefore need a new replacement server.System went down on 4th dec 2023 due to water on the server, this caused treatment delay for at least 2 weeks.The customer refused to give us any patient data.

• Brand Name: ARIA RADIATION THERAPY MANAGEMENT
• Common Device Name: ARIA RTM (SOFTWARE MEDICAL DEVICE)
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; täfernstrasse 7; daettwil 5405 ; SZ 5405
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 18426624
• Report Number: 3010123525-2024-00001
• Device Sequence Number: 7731450
• Product Code: IYE
• UDI-Device Identifier: 00856100006165
• UDI-Public: 856100006165
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K173838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/02/2024

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: HITA870
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/02/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown