MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY HI-ART TREATMENT SYSTEM; TOMOTHERAPY TREATMENT SYSTEM

Model Number 104430

Device Problems Thermal Decomposition of Device (1071); Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Accuray has identified an issue that relates to the high-performance patient couch.Under certain circumstances when the user initiates patient couch motion in the z-direction for patient setup or patient unloading using the keypad or positioning control panel (pcp) it may exhibit unintended descent.The root cause of the issue was determined to be the control system's handling of the motion feedback loss within the vertical drive actuator.Accuray has initiated a field correction to address this issue within 3003873069/11/15/2017/001c in the form of a software patch and replacement of cables within the couch subsystem.

Event Description

It was reported that the couch had an unexpected descent of ~15 cm whilst the customer was commanding an upwards move via couch control keypad (cck).Burn marks were observed on the braking resistor board (brb).No patient was present at the time of the event.

• Brand Name: TOMOTHERAPY HI-ART TREATMENT SYSTEM
• 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: 7047496
• MDR Text Key: 93216323
• Report Number: 3003873069-2017-00016
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 104430
• Device Catalogue Number: 104430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2017
• 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: 3003873069/11/15/2017/00
• Patient Sequence Number: 1