MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY TREATMENT DELIVERY SYSTEM; MEDICAL LINEAR ACCELERATOR

Model Number	H-SERIES
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer alleged the couch rose up without cck (couch control keypad) and pcp (positioning control panel) control and no error recorded in rds (radiation delivery system)-log.There are no known injuries.
Event or Problem Description
Couch fault, cck (couch control keypad) could not stop couch movement.
Additional Manufacturer Narrative
The investigation concluded that the cause of the event was due to the hardware.In order to resolve the issue, the cca (couch control assembly) was replaced.No harm was caused to the patient.The risk was determined to be acceptable.
Additional Manufacturer Narrative
Udi related data quality updates only.Previously reported udi was found to be incorrect due to a copy and paste issue in service record.The corrected udi has been added to field d4 of this report.

• Brand Name: TOMOTHERAPY TREATMENT DELIVERY SYSTEM
• Common Device Name: MEDICAL LINEAR ACCELERATOR
• 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 ; 1240 deming way; madison, WI 53717 ; 6082842971
• MDR Report Key: 17862009
• Report Number: 3003873069-2023-00015
• Device Sequence Number: 12194888
• Product Code: IYE
• UDI-Device Identifier: M65810182840
• UDI-Public: +M65810182840/16D20180621P
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K121934
• 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,Followup
• Report Date (Section B): 09/25/2024

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
• Device Model Number: H-SERIES
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 09/18/2023; Not provided
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 01/10/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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