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

Model Number TOMOTHERAPY TREATMENT DELIVERY SYSTEM WITH IDMS

Device Problem Loss of Data (2903)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

The event will be fully investigated to determine if further action is needed.

Event Description

A fraction was delivered and completed normally without errors, but the system did not mark the fraction as completed.

Event Description

A fraction was delivered and completed normally without errors, but the system did not mark the fraction as completed.

Manufacturer Narrative

The event will be fully investigated to determine if further action is needed.

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 after an error occurred during fraction loading and user shuts down the machine before the treatment is initiated).There has been no patient 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 should only 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.

Manufacturer Narrative

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.

• Brand Name: TOMOTHERAPY TREATMENT DELIVERY SYSTEM WITH IDMS
• Type of Device: MEDICAL LINEAR ACCELERATOR
• Manufacturer (Section D): ACCURAY INCORPORATED; 1209 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717 ; 6088242971
• MDR Report Key: 13175552
• MDR Text Key: 285610491
• Report Number: 3003873069-2022-00001
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00811376030221
• UDI-Public: (01)00811376030221(11)210929
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K212794
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 01/06/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TOMOTHERAPY TREATMENT DELIVERY SYSTEM WITH IDMS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1