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

Model Number H29

Device Problems Electrical /Electronic Property Problem (1198); Failure to Sense (1559); Electrical Overstress (2924)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

The affected accelerator was cleaned and fitted with replacements for the heat exchanger, kilovoltage x-ray unit, and smoke-damaged parts.The repaired accelerator was tested to be functioning within design specifications.The accelerator was returned to clinical operation after acceptance testing by hospital radiotherapy staff.The fire-damaged heat exchanger assembly and attached kilovoltage imaging x-ray tube assembly were removed from the site and returned to the manufacturer for inspection.The investigation into root cause is ongoing.

Event Description

While preparing for a patient treatment, smoke was seen emanating from the accelerator gantry.Patient and staff were immediately evacuated from the treatment room without injury.Hospital staff responding to the incident discovered fire from a localized flame behind the system covers in the kv imaging system's heat-exchanger assembly and worsening smoke.The fire was extinguished.Flame damage was limited to the heat-exchanger assembly.Smoke and soot caused damage to other accelerator subsystems.The fire-damaged heat-exchanger assembly and attached kv imaging x-ray tube assembly were removed and returned to the manufacturer for inspection.Investigation into root cause is ongoing.A final report will be filed upon completion of the investigation.

Manufacturer Narrative

The root cause was a locked rotor condition in the heat exchanger pump motor caused by failure of the rotor bearings.With the rotor locked and the motor windings still energized, the motor's thermal protection switch cycled repeatedly to the point of failure and the motor eventually overheated to the point of deteriorating an oil hose and inducing an electrical failure.These conditions in turn led to ignition of a localized fire that was promptly handled.This is the only known occurrence of this failure mode.After performing a risk analysis of this event, varian has determined that this failure mode is unlikely to result in serious injury and, upon further review, does not meet the requirements for reporting.No additional follow-up to this mdr.(b)(4).

• Brand Name: VARIAN CLINAC-IX
• Type of Device: LINEAR ACCELERATOR
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC.; 911 hansen way; palo alto CA 94304 1028
• Manufacturer (Section G): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304 1028
• Manufacturer Contact: jeffrey semone ; 911 hansen way; palo alto, CA 94304-1028 ; 6504241028
• MDR Report Key: 5096505
• MDR Text Key: 26508129
• Report Number: 2916710-2015-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K131807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: H29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1