MAUDE Adverse Event Report: ACCURAY INCORPORATED RADIXACT TREATMENT DELIVERY SYSTEM

Medical Device Problem Codes	Computer Software Problem (1112); Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer alleged that the machine froze 99.4% into a scan and the gantry panels showed "radiating" with a patient in the gantry.Currently, there is no known injury to the patient.Issue is currently under investigation.
Event or Problem Description
Gantry panels show "radiating" with patient in the gantry.
Additional Manufacturer Narrative
"customer alleged that the machine froze 99.4% into a scan and the gantry panels showed ""radiating"" with a patient in the gantry.There are no known injuries.The investigation found that when the issue occurs, the scs appears to hang immediately after kv delivery completes.The couch continues to move into the bore until the user intervenes or the couch reaches the end stop.Possible causes include a deadlock or an unhandled exception that causes several threads to go down.In all instances, kv radiation stops at the expected time (before the issue arises).An anomaly was identified.Total risk is acceptable.The customer can clear the issue with a reboot.In conclusion, there have been no injuries.The system has been rebooted and no further actions are required.The issue is being tracked and fixed through the anomaly.".

• 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: 16765518
• Report Number: 3003873069-2023-00008
• Device Sequence Number: 11522504
• Product Code: IYE
• UDI-Device Identifier: 00811376030009
• UDI-Public: 010081137603000911210105
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Other
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2021
• 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