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

Model Number 10000, 20000

Device Problem Excessive Heating (4030)

Patient Problem No Patient Involvement (2645)

Event Date 09/30/2020

Event Type  malfunction  

Event Description

During internal testing view ray identified two situations where components of the receive coil can reach elevated temperatures, which has the potential to cause a burn injury to the patient or user.View ray determined that the receive coil feed board box, exceeded temperature specifications during use of sequences requiring increased rf power (e.G.8fps cine imaging) when it is in proximity (<15cm) to the bore wall in meridian linac system (p/n 20000).View ray determined that the optional two frames per second in three planes cine tracking feature in use in the meridian system (p/n 10000) may also cause unexpected heating of the receive coil feed board box.This issue has only been reported through internal testing.To date, there have been no customer reports related to this issue.

• Brand Name: MRIDIAN AND 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: 10719261
• MDR Text Key: 213063264
• Report Number: 3011233554-2020-00001
• Device Sequence Number: 1
• Product Code: IYE
• 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: 10/22/2020

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
• Device Operator: Other
• Device Model Number: 10000, 20000
• Device Catalogue Number: 10000, 20000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 10-20-2020-001-C
• Patient Sequence Number: 1