MAUDE Adverse Event Report: ACCURA, OWNER OF TOMOTHERAPY MADISON WIS TOMOTHERAPY TREATMENT MACHINE

Model Number HI-ART

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/11/2017

Event Type  malfunction  

Event Description

Possible system error with possible over dose of radiation by 8.4%.Diagnosis or reason for use: treatment for cancer."is the product compounded: no, is the product over-the-counter: no.".

• Brand Name: TOMOTHERAPY TREATMENT MACHINE
• Type of Device: TOMOTHERAPY TREATMENT MACHINE
• Manufacturer (Section D): ACCURA, OWNER OF TOMOTHERAPY MADISON WIS; sunnyvale VA
• MDR Report Key: 7147558
• MDR Text Key: 95940099
• Report Number: MW5074231
• 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: Physicist
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HI-ART
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other