MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC CLINAC 600C; LINEAR ACCELERATOR

Model Number 600C

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 12/02/2016

Event Type  malfunction  

Event Description

Staff were trying to use the clinac 600c linear accelerator to treat a patient and kept getting mlc faults.The treatment for the patient on the table was rescheduled and all other patients for the day were rescheduled or completed on the clinac 2100 lin acc right next to it.We had our contract service vendor come out and they found a motor in mlc (multileaf collimator) had failed.They replaced the motor, tested operation, and returned to customer for use.

• Brand Name: CLINAC 600C
• Type of Device: LINEAR ACCELERATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC; 3100 hansen way; palo alto CA 94304
• MDR Report Key: 6529252
• MDR Text Key: 73932269
• Report Number: 6529252
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2017

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: 600C
• Other Device ID Number: 260
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2017
• Device Age: 22 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 04/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1