MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY HD; TOMOTHERAPY TREATMENT SYSTEM

Model Number 1018283

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 04/04/2018

Event Type  malfunction  

Manufacturer Narrative

Accuray has identified a failure that resulted in an unexpected descent of the high-performance patient couch.The event occurred following an upgrade of the system software to version 5.1.2--an upgrade intended to detect and mitigate this type of system behavior.The 5.1.2 software detected the behavior earlier than previous versions and mitigated the severity of the event.Investigation has determined the cause of the event to be a new failure mode and solutions are in development.

Event Description

It was reported that the couch had an unexpected descent of 100mm (4 inches) during patient setup.There was no injury to patient or medical staff reported.

• Brand Name: TOMOTHERAPY HD
• Type of Device: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1240 deming way; madison,
• Manufacturer Contact: tran do ; 1240 deming way; madison, WI 53717 ; 4087894378
• MDR Report Key: 7398239
• MDR Text Key: 104551714
• Report Number: 3003873069-2018-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K082005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/04/2018

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
• Device Operator: Health Professional
• Device Model Number: 1018283
• Device Catalogue Number: 1018283
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0287-2018
• Patient Sequence Number: 1