MAUDE Adverse Event Report: VARIAN TRUEBEAM; LINEAR ACCELERATOR

Model Number H19

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Death (1802)

Event Date 06/28/2018

Event Type  Death  

Manufacturer Narrative

Site reported to varian that the patient was strapped down for treatment but somehow became unstrapped and at that point fell off the couch.During the fall the patient impacted the gantry with their head and landed on the ground.The patient suffered multiple major injuries due to the fall and age of patient.The patient passed away as a result of the injuries.There has been no report or finding that the varian device has malfunctioned.This issue is attributed to human error.

Event Description

According to the user site, the patient was strapped to the couch during treatment and somehow became unstrapped and subsequently fell off the couch from treatment height.The site reported the patient was taking medication to keep them calm.The user site believes the medication wore off and the patient tried to get up from the couch.The patient suffered multiple major injuries including head impact with the gantry and multiple broken bones from the impact with the ground.The patient passed away as a result of the injuries.Varian was not requested on site for any service related to this incident or the truebeam.The user site stated varian's truebeam operated as intended and the site is continuing to investigate the incident to determine the cause of the fall.Additional information provided by the site included that the patient had fragile bones from cancer and had suffered some previous injuries.User site declined to provide any further details.

• Brand Name: TRUEBEAM
• Type of Device: LINEAR ACCELERATOR
• Manufacturer (Section D): VARIAN; 911 hansen way; palo alto CA 94304 1028
• Manufacturer (Section G): VARIAN; 911 hansen way; palo alto CA 94304 1028
• Manufacturer Contact: jeffrey semone ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 7697385
• MDR Text Key: 114271827
• Report Number: 2916710-2018-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: H19
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2013
• 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): Death