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

Model Number	20000
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907); Mechanical Jam (2983); Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is due to a retrospective review of a health hazard evaluation (hhe) and the remote potential for serious injury to service personnel.The 806.20 recall for this issue has been completed and field change notice fcn-0001 track roller lubrication instructions initial service, fcn-0002 gantry track-roller health and bogey alignment inspection and fcn-0003 gantry track-roller health and bogey alignment inspection.The inspection of the gantry track roller health is now included with preventative maintenance.Viewray has not received any reports of serious injury to the affected groups including patients, users and service personnel.
Event or Problem Description
Viewray's distributor reported an occurrence where the gantry came off the vault plate and produced an error message.The system displayed error message rt08011 with a dialog message stating "gantry motor operating current limits have been exceeded.Call service." this error code is a hardware error.The error code is caused by hardware issue.The system shows the error message and aborts treatment if in session.The user should call viewray service.

• 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: 13191204
• Report Number: 3011233554-2022-00001
• Device Sequence Number: 4315084
• Product Code: IYE
• UDI-Device Identifier: 10868029000305
• UDI-Public: 011086802900030511200220
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection,Modification/Adjustment,Recall,Other,Repair
• Type of Report: Initial
• Report Date (Section B): 01/07/2022

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): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2020
• Initial Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown