MAUDE Adverse Event Report: ACCURAY INCORPORATED ACCURAY PRECISION TREATMENT PLANNING SYSTEM; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Model Number	TOMOTHERAPY TREATMENT DELIVERY SYSTEM WITH IDMS
Medical Device Problem Code	Loss of Data (2903)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event will be fully investigated to determine if further action is needed.
Event or Problem Description
A fraction was delivered and completed normally without errors, but the system did not mark the fraction as completed.
Additional Manufacturer Narrative
The reported event may occur at healthcare facilities using at least 2 tomotherapy treatment delivery systems, when transferring a patient from one tomotherapy system machine to another under specific circumstances (patient transferred afteran error occurred during fraction loading and user shuts down the machine before the treatment is initiated).There has been nopatient death or serious injury.The root cause is an anomaly in software design: the unload fraction processed by the software did not require that unload shouldonly be permitted from the treatment machine where the fraction was originally downloaded.The following action is being implemented: software patch installation to correct the anomaly.During the investigation, it was initially determined that the root cause was the tomotherapy treatment delivery system with idms, however further investigation determined that the issue is with the precision treatment delivery system.
Additional Manufacturer Narrative
Added cause inv - inv findings code and cause inv-invconclusion code.

• Brand Name: ACCURAY PRECISION TREATMENT PLANNING SYSTEM
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• 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: 13716685
• Report Number: 3003873069-2022-00006
• Device Sequence Number: 4807309
• Product Code: MUJ
• UDI-Device Identifier: 00811376030221
• UDI-Public: (01)00811376030221(11)210929
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K212794
• 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: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2002
• 2 Devices were Involved in the Event: 1 2

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: TOMOTHERAPY TREATMENT DELIVERY SYSTEM WITH IDMS
• 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: 03/02/2022
• Supplement Date Received by Manufacturer: 03/02/2022; 03/02/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 05/26/2022; 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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