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

Device Problems Improper Device Output (2953); Issue With Displayed Error Message (2967); Radiation Overexposure (3017)

Patient Problem No Information (3190)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

While treating the patient's breast field 1 with radiation, they received a high voltage circuit breaker (hvcb) fault which interrupted treatment for this field delivering 74 out of 82 monitor units (mu's).Unable to clear the fault, the clinician got the patient off the table, cleared the fault by resetting the breaker and put the patient back on the table where they received the partial treatment message that stated "74/82 mu was delivered do you wish to continue with the treatment which has a remainder of 8 mu".The clinician selected ok and "beamed on".The clinician noticed that the beam did not stop at 8mu so she hit "beam off button" at which by this time 29 mu's was delivered to this field which gave an additional 21 mu's not planned.They spoke with their physicist and continued to treat the other fields in the plan; however, the plan is still displaying that field 1 was only partially treated with the delivered mu of 74/82.

• Type of Device: LINEAR ACCELERATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS INC.; 3100 hansen way; palo alto CA 94304
• MDR Report Key: 4146593
• MDR Text Key: 4784384
• Report Number: 4146593
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/26/2014

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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 10/07/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2014
• Patient Sequence Number: 1