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

Model Number 20000-1

Device Problems Radiation Overexposure (3017); Radiation Underexposure (3018)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

This issue does not affect systems using the english user interface (ui); it only affects sites using the (b)(6), german or italian ui.Investigation identified the root cause as follows: the treatment planning and delivery system (tpds) communicates the gating algorithm settings to the treatment delivery computation unit (tdcu) using an.Xml file.The values for "% roi" and "confidence threshold" are documented as numerical values.These values are then converted to text in an.Xml file.The communication message is then sent from the delivery ui to the tdcu using the european decimal notation when tpds is set to (b)(6), italian or german languages.The numerical value does not get converted to the values expected by the tdcu.The tdcu is expecting a neutral decimal notation as in the english ui.

Event Description

A user of viewray's mridian linac system reported an occurrence where a change to the region of interest (roi) made in the "edit tracking" window was not reflected in treatment delivery in the (b)(6) language user's interface (ui) version.The roi always defaults to 5%.The site further reported the confidence threshold does not work at anything other than default 50% in (b)(6) language ui version.

• 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: 11748288
• MDR Text Key: 268047235
• Report Number: 3011233554-2021-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K170751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20000-1
• Device Catalogue Number: 20000-1
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1