MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC. TRUEBEAM RADIOTHERAPY SYSTEM; ACCELERATOR, LINEAR, MEDICAL

Model Number 2.7

Device Problems Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

Reports over the course of the past six months have been made to varian, truebeam's manufacturer, regarding the multiple downtimes the machines have been experiencing which has caused the cancellation of well over 100 different patient's radiation therapy for cancer therapy.Issues include difficulties with the devices internal power supply, fault in the image storing server, and fault in the collimator.

• Brand Name: TRUEBEAM RADIOTHERAPY SYSTEM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.; 3100 hansen way; palo alto CA 94304
• MDR Report Key: 14732343
• MDR Text Key: 294259928
• Report Number: 14732343
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00899475002233
• UDI-Public: (01)00899475002233
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/12/2022,03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2.7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/12/2022
• Device Age: 9 YR
• Date Report to Manufacturer: 06/17/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1