MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY H SERIES; TOMOTHERAPY TREATMENT SYSTEM

Model Number 1018284

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

The customer was attempting to position the couch for morning qa when the couch descended to the hard stop.The head lda (lateral drive assembly) collided with the gantry during descent.Only cosmetic damage to the gantry cover was observed.The log analysis showed 11 error instances and a couch descent of 85mm (3.3 inches).The vda (vertical drive assembly), servoamp and brb (braking resistor board) were replaced and the site was updated to 5.1.4 software to mitigate the issue.

Event Description

It was reported that the couch had an unexpected descent and collided with the gantry.There was no patient on the table and no injury reported.

• Brand Name: TOMOTHERAPY H SERIES
• Type of Device: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1240 deming way; madison WI 53717
• Manufacturer Contact: daniel biank ; 1240 deming way; madison, WI 53717
• MDR Report Key: 8951883
• MDR Text Key: 195587127
• Report Number: 3003873069-2019-00010
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082005
• 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: Repair
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1018284
• Device Catalogue Number: 1018284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2014
• 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