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

Model Number 1018286

Device Problems Component Falling (1105); Failure to Advance (2524); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2017

Event Type  malfunction  

Manufacturer Narrative

The braking resistor board, vda actuator, brb to servo amp cable and vda servostar were returned and pending analysis on the day of this report.

Event Description

It was reported that the couch would not move in the z-axis when the user attempted to control it from the couch control keypad (cck).However, when the positioning control panel (pcp) was used it moved in the vertical direction with unusual noise.Accuray support inspected the braking resistor board (brb) and cables.No burnt marks or bad connections were discovered.The vertical drive assembly (vda), brb, and both cables from the vda to servo star were replaced.Accuray support also replaced the battery pack, calibrated and tested the couch with no error.Upon follow-up field personnel indicted that there was 10-15cm of unexpected z axis movement.When trying to move the couch for the 5 minute warm-up from the unload position, it descended after moving 3mm in the positive z.No patient was on the couch.There was no report of death or serious injury.If additional information is received a follow-up report will be sent.

• Brand Name: TOMOEDGE TREATMENT SYSTEM
• Type of Device: TOMOTHERAPY TREATMENT SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• Manufacturer Contact: adam st. sauver ; 1310 chesapeake terrace; sunnyvale, CA 94089 ; 6087164731
• MDR Report Key: 6663977
• MDR Text Key: 78367666
• Report Number: 3003873069-2017-00008
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: 1018286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1