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

Model Number H29

Device Problem Mechanical Jam (2983)

Patient Problems Edema (1820); Dyskinesia (2363)

Event Date 01/04/2015

Event Type  Injury  

Event Description

The patient was on the treatment table and the therapist moved the gantry from the dedicated key board to prepare for the next treatment field.When the gantry was moved to 0 degrees the dedicated keyboard buttons became stuck.The gantry did not stop, and hit the patient while the patient was on the table.The patient received medical attention due to the incident which included the following: ct, mri, ultrasonic, and blood test.The test show subcutaneous dropsy on the back.Doctor has administered pain reliever for stomach and neurotrophic medicine for legs dyskinesia.The patient is under ecg monitoring, and oxygen uptake.After the issue was reported the dedicated keyboard and gantry motion were tested on site by varian service and the system operated as designed during testing with no malfunction.The dedicated keyboard was replaced.

Manufacturer Narrative

Actual device was evaluated on site when the issue was reported.The device has been requested to be returned for the investigation.Though still under investigation, varian has determined that a mdr is appropriate, due to the serious injury that occurred.Additional f/u to this mdr is expected upon completion of the investigation.(b)(4).

• Brand Name: VARIAN CLINAC
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS, INC; palo alto CA
• Manufacturer Contact: jeff semone,sr. dir. ; 911 hansen way, ms c260; palo alto, CA 94304 ; 6504246833
• MDR Report Key: 4417744
• MDR Text Key: 5163964
• Report Number: 2916710-2015-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H29
• Other Device ID Number: 9.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2015
• Initial Date FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR