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

Device Problems Connection Problem (2900); Positioning Problem (3009); Device Fell (4014)

Patient Problems Head Injury (1879); Headache (1880)

Event Date 10/23/2020

Event Type  malfunction  

Event Description

Patient was struck in the head with a machine panel.Cancer center manager follow up: name/identifiers off machine, varian trilogy.How is the patient? patient had a headache.Doctor checked in on patient throughout the weekend.I have not received an update as of yet, but patient was just treated and stated she had a headache all weekend.Who is going to service this machine and when: machine was serviced and the only deduction was the clips were not properly secured after the service.Tech could not reproduce the incident while on site.Clips were locked and machine was put back into service.The service technician told doctor and manager, that the most likely outcome was that the clips were not secured.The service tech who serviced the machine in the p.M, he was also the tech who came back on site next day a.M.He unlocked the clips and tried to reproduce what was explained to him, as well as the picture shared with him from physics as to how the machine looked when the cover shifted and came into contact with the patient.The company is (b)(4).I also asked our physicists if a service call report had been provided.I was told no.I asked that they inquire about receiving one for both day's calls.Physician has noted in ecw (eclincalworks) a phone note about the incident and her follow up with the patient.Vendor note: i received a phone call from the therapists stating that the trilogy's mv arm was stuck and not moving.The fault asserted by the obi (on-board imaging) system indicated a shoulder and elbow velocity was incorrect while moving the arm.This fault was asserted as soon as motion was attempted rendering the arm unable to move and stuck.I received the call at around 4:20pm.I had parts delivered to me and i got to the site at around 6pm.I troubleshot the problem to the mv arm's motor driver board pcb located in the gantry.I replaced the board and tested the trilogy.I found the problem to be gone and continued testing for operation.I rotated the gantry to ensure covers were seated then set the machine into its stand-by state.I received a phone call [next day] at around 8:10am stating a cover on the trilogy had fallen off.The cover described was the center cover on the gantry.I received a phone call from the doctor stating the cover had hit a patient.I arrived at the site at around 9:10am.I inspected the trilogy and found no damage to the machine.I inspected the latches to the cover and found they were operational and disengaged.I inspected the side panels that contained the latches and determined they were functional.I inspected the guide pins for the cover and determined they were functional and fine.I attempted to reproduce the cover falling off the machine as described by the therapists on site.With the latches engaged the cover would not fall off the machine with gantry rotation.With the latches disengaged but the pins seated, i found the cover would not fall off the machine with gantry rotation.With the latches disengaged and the pins not seated i found the cover would shift and make an audible noise, but not fall with gantry rotation.With the latches disengaged, the pins not seated, and the cover visibly improperly seated, i found the cover would fall on gantry rotation, usually after a shift with an audible noise.Each time the cover fell it fell sideways without contacting the patient support couch.I could not reproduce the scenario described by the therapists.I reseated the cover, engaged the latches on the cover and notified physics of the repair.Patient initially experienced a headache.No contusions etc.No injury per patient.

• Brand Name: TRILOGY
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 2101 4th avenue, suite 100; seattle WA 98121
• MDR Report Key: 10785171
• MDR Text Key: 214594787
• Report Number: 10785171
• 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: 10/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 10/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA