MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS, INC.; ACCELERATOR, LINEAR, MEDICAL

Lot Number 70000

Device Problems Mechanical Problem (1384); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2022

Event Type  malfunction  

Event Description

During the patient's treatment the gantry on linac had a fault, which in turn causing the treat delivery to stop in the process of delivery.Our engineer was notified, we got the patient off the table.Further test ran and determined part replacement need.Spoke with md and determine patient received 90% of dose and is okay with amount delivered.

• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.; 911 hansen way; palo alto CA 94304
• MDR Report Key: 16145932
• MDR Text Key: 307186641
• Report Number: 16145932
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 70000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Sex: Female