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

Model Number 1018283

Device Problem Mechanical Problem (1384)

Patient Problem Pain (1994)

Event Date 10/05/2018

Event Type  malfunction  

Manufacturer Narrative

The couch had an unexpected descent of 103mm (~4 inches).The z-axis encoder, vda and cca were replaced.The patient complained of back pain after the descent.The event occurred after the system had been upgraded to 5.1.3.This upgrade contained fixes introduced in a patch to detect, mitigate and lessen the severity of this type of system behavior.

Event Description

It was reported that the couch had an unexpected descent with a patient on the table.The patient complained of back pain but no serious injury or death occurred.

• Brand Name: TOMOTHERAPY HD
• Type of Device: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1240 deming way; madison WI 53717
• Manufacturer Contact: adam st. sauver ; 1240 deming way; madison, WI 53717 ; 6088243417
• MDR Report Key: 8006158
• MDR Text Key: 126271409
• Report Number: 3003873069-2018-00004
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• 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