MAUDE Adverse Event Report: VIEWRAY, INCORPORATED MRIDIAN LINAC SYSTEM; MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM

Model Number	20000-01
Medical Device Problem Code	Failure to Recalibrate (1517)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 20april2023 a user of viewray's mridian linac system reported an issue with their system's gantry angles measuring 1.7 degrees out of specification.On (b)(6) 2023 the gantry offsets were confirmed to be within specifications.Due to a mistake by a site operator on (b)(6) 2023, an emergency stop was mistakenly pressed causing the system to power down.Upon powering the system back on, the viewray onsite engineer identified that the inclinometer had failed resulting in an inclinometer replacement.On (b)(6) 2023, the site irradiated one patient and after treatment, the site discovered during quality assurance checks that the gantry angle was 1.7 degrees off.The site reported there were no consequences for the patient since the target volume was central and symmetrical, and therefore no relevant dose deviations occurred.This was confirmed by recalculation in the radiation planning system with different gantry angles.On (b)(6) 2023 viewray field service engineer calibrated the inclinometer and gantry offsets back to 0.0 degrees.The customer performed a starshot analysis to verify and confirm the inclinometer and gantry angles were within specifications.
Additional Manufacturer Narrative
Viewray is in process of obtaining additional information.A final report will be sent upon completion of the investigation.
Additional Manufacturer Narrative
The root cause investigation was identified as a process failure occurred resulting in incorrect "inclinometerhardoffset" values within the motion controller "machinedata" file being used after system acceptance.Corrective action was initiated for this issue and no further action required, this issue was identified to be a one-off event caused by the incorrect data file being uploaded and the system not being commissioned correctly.

• Brand Name: MRIDIAN LINAC SYSTEM
• Common Device Name: MEDICAL CHARGED-PARTICLE RADIATION THERAPY SYSTEM
• Manufacturer (Section D): VIEWRAY, INCORPORATED; 815 e. middlefield road; mountain view CA 94043
• Manufacturer (Section G): VIEWRAY, INCORPORATED; 815 east middlefield road; mountain view CA 94043
• Manufacturer Contact: patrick jones ; 815 east middlefield road; mountain view, CA 94043 ; 7196495345
• MDR Report Key: 17101286
• Report Number: 3011233554-2023-00002
• Device Sequence Number: 20784334
• Product Code: IYE
• UDI-Device Identifier: 00868029000346
• UDI-Public: 010086802900034611200821
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K212958
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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: 20000-01
• Device Catalogue Number: 20000-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2023
• Supplement Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown