MAUDE Adverse Event Report: VIEWRAY, INC. MRIDIAN LINAC; RADIATION THERAPY

Model Number 20000

Device Problem Program or Algorithm Execution Problem (4033)

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

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr is a retrospective report.A previous occurrence of this issue was reported as mfr report #: 3011233554-2019-00006 and associated with recall 30112335544-11-18-19-003-c.This issue was in the recall but was not individually reported as an mdr.The recall for this issue has been completed and a software patch was released.Viewray has not received a customer report of incorrect dose application or significant delay in treatment due to this issue.

Event Description

A user of viewray's mridian linac system reported an occurrence in the planning/fusion workflow where: 1.Manual translation shift cannot be applied correctly to secondary dose volume when secondary dose and secondary ct comes from other vendor a.Manually align secondary ct and primary mri.B.Apply the same translation value to the secondary dose which is associated to the ct.C.Observed that secondary dose volume is not aligned with primary mri and registered ct.2.Manual translation shift cannot be applied correctly to secondary dose volume when secondary dose and secondary mri generated from mridian system but at a different fov compared to primary mri.A.Manually align secondary mridian mri and primary mridian mri.B.Apply the same translation value to the secondary dose which is associated to the secondary mridian mri.C.Observed that secondary dose volume is not aligned with primary mri and registered mri.

• Brand Name: MRIDIAN LINAC
• Type of Device: RADIATION THERAPY
• Manufacturer (Section D): VIEWRAY, INC.; 815 e. middlefield rd.; mountain view CA 94043
• Manufacturer (Section G): VIEWRAY, INC.; 815 e. middlefield rd.; mountain view CA 94043
• Manufacturer Contact: debra cavallaro ; 815 e. middlefield rd.; mountain view, CA 94043 ; 4088287386
• MDR Report Key: 12913779
• MDR Text Key: 284632648
• Report Number: 3011233554-2021-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 10868029000305
• UDI-Public: 011086802900030511200827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20000
• Device Catalogue Number: 20000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 30112335544-11-18-19-003
• Patient Sequence Number: 1