MAUDE Adverse Event Report: ACCURAY TOMOTHERAPY HD

Model Number 390

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  No Answer Provided  

Event Description

As required by the (b)(6) rules and regulations, we are writing to inform you of a recent documentation error due to a defect in accuracy tomography equipment software.The error did not result any patient harm or inadvertent treatment.The glitch was contained in the software and was monitored daily by staff.The accuracy manufacturer resolved the issue by january 1, 2018 and no further issues have been reported.On (b)(6) 2017 - therapists noticed that the number of fractions reported in aria (electronic medical record) is one less than the true number of fractions reported in tomotherapy.Therapists informed physicists immediately.On (b)(6) 2017 - physicists confirmed that the rt records were not automatically exported by the ois to aria since (b)(6) 2017.Physicists exported all fractions from (b)(6) manually.The problem was reported to radonclt department and administration.At manual import of fractions it was noticed that one patient's records showed double the amount of dose actually delivered.On (b)(6) 2017 - accuray and varian customer support lines were called to assist.On (b)(6) 2017- therapists noticed that 'elapsed days' for patients who started treatment before (b)(6) is about 30 days longer than the true number of elapsed days.Therapists informed physicists.On (b)(6) 2017 - accuray, varian and administration were made aware of the problem with the discrepancy in 'elapsed days'.On (b)(6) 2017 - accuray sent out a customer supplement outlining the issues described above.On (b)(6) 2018 - issue resolved by accuray.No further issues noted.Please do not hesitate to contact me for any questions or concerns at (b)(6).Cordially,(b)(6).

• Brand Name: TOMOTHERAPY HD
• Type of Device: TOMOTHERAPY
• Manufacturer (Section D): ACCURAY
• MDR Report Key: 7181682
• MDR Text Key: 97374634
• Report Number: MW5074528
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 390
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1