MAUDE Adverse Event Report: VARIAN TRUEBEAM; ACCELERATOR, LINEAR, MEDICAL

Model Number 100052696-02

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 04/18/2018

Event Type  malfunction  

Event Description

Reusable srs cone plugged into device, but not fully.Device is not to work if this part is not fully plugged in but device was functioning, when machine turned, srs cone fell out of machine, did not impact patient.

• Brand Name: TRUEBEAM
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): VARIAN; palo alto CA 94304
• MDR Report Key: 7475316
• MDR Text Key: 107147974
• Report Number: MW5076926
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100052696-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 149 YR