MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS CLINAC 21IX; ACCELERATOR, LINEAR, MEDICAL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Event Description

The 21ix linear accelerator experienced a gfil fault and was declared down beginning at 12:30pm.13 patients needed to have their appointments rescheduled.Biomed and varian engineer were on site.Machine repair performed and post repair qa performed.Machine was released for clinical use at 6am the following day.

• Brand Name: CLINAC 21IX
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304
• MDR Report Key: 12224412
• MDR Text Key: 263387946
• Report Number: 12224412
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2021

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2021
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1