MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH INFORMATION SYSTEM; ARIA RADIATION THERAPY MANAGEMENT

Model Number	HIT0733
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer claimed that cyber-attack happened on their system.According to the submission the production aria network went down on 26th of september, 2024 incident has been reported to varian on 27th of september, 2024.The customer's allegation is confirmed by field activities.As of today the treatment on site is not started again since the cyber-attack.No allegation of malfunction is made against aria applications related to infection, which are determined to be working as intended.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.In order to prevent future attacks, customer facing documentation is available to varian customers.Security implementation guides and documentation on disaster contingency reports are also available to varian customers.
Event or Problem Description
Site experienced a cyberattack on september 26th.All servers have been taken offline while the customer goes through their network to see what all was affected.Nothing has been reported to varian at this time on if our servers were a part of the attack.
Additional Manufacturer Narrative
Treatment started again at the customer site on (b)(6) 2024.
Event or Problem Description
See completed mw-2024-00003, mfr 3003094912-2024-00001.
Additional Manufacturer Narrative
Treatment started again at the customer site on (b)(6) 2024.
Event or Problem Description
See completed (b)(4).Mfr 3003094912-2024-00001.

• Brand Name: INFORMATION SYSTEM
• Common Device Name: ARIA RADIATION THERAPY MANAGEMENT
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS IMAGING LABORATORY GMBH; taefernstrasse 7; daettwill 05405
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 20533366
• Report Number: 3003094912-2024-00001
• Device Sequence Number: 12432838
• Product Code: IYE
• UDI-Device Identifier: 00856100006110
• UDI-Public: 00856100006110
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/12/2024

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: HIT0733
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 09/27/2024; 09/27/2024
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 11/11/2024; 11/12/2024
• 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