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

Model Number	20000
Medical Device Problem Code	Program or Algorithm Execution Problem (4033)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011233554-2021-00002
• Device Sequence Number: 5085815
• Product Code: IYE
• UDI-Device Identifier: 10868029000305
• UDI-Public: 011086802900030511200827
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170751
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 20000
• Device Catalogue Number: 20000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 30112335544-11-18-19-003
• Patient Sequence Number: 1
• Patient Sex: Unknown