MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The status console is not stopping the radiation following the rx 3.0.2.1 update.
Additional Manufacturer Narrative
Customer alleged that the status console key nor pressing the stop button could stop the radiation.Currently, there is no known injury.This issue is currently under investigation.
Additional Manufacturer Narrative
Customer alleged that the status console key nor pressing the stop button could stop the radiation.Currently, there is no known injury to the patient.During investigation, two failures were identified in testing.The first case causes a system failure, but the system fails safely and will not run.The second case causes a system failure, but the system continues operating and the error is not detected.Root cause of the original issue was a faulty stationary control system (scs) interlock circuit design that prevented the status console and couch from being able to properly control the interlock.Once the issue was corrected with an updated design, bunker testing was repeated to confirm resolution of the issue.In-depth studies of the interlock functionality were performed to determine the safety risk related to radiation exposure due to the interlock not functioning as expected.It was determined that the safety risk was negligible as the secondary methods of interlock and radiation control were fast enough to meet product and regulatory specifications (100ms to terminate radiation from an interlock fault iec 60601).The root cause of this issue was incorrect rework of an scs board (scb front board).Certain components were supposed to be removed from the board when reworking, but they were missed.In conclusion, there have been no injuries.The part was replaced to resolve the issue for the customer.No further actions are required.The design has already been corrected and all impacted scs components in the service network were returned and reworked.

• Brand Name: RADIXACT TREATMENT DELIVERY SYSTEM
• Common Device Name: RADIXACT
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer (Section G): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1209 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 17086990
• Report Number: 3003873069-2023-00011
• Device Sequence Number: 12305291
• Product Code: IYE
• UDI-Device Identifier: 00811376030009
• UDI-Public: 010081137603000911200415
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K161146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2020
• 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