MAUDE Adverse Event Report: VARIAN MEDICAL SYSTEMS PROBEAM® PROTON VERSION 2.8; PROBEAM® PROTON THERAPY SYSTEM

Model Number HGA0032

Device Problems Computer Software Problem (1112); Installation-Related Problem (2965)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

The imaging supervisor workstation failed to boot.The standard protocol at this site is build a new flash drive with the operating system and configuration files specific to that room.Unknowingly the compact flash drive contained data from a previous point and time for which the imaging isocenter did not match the actual treatment room.This led to a discrepancy of up to a 3 mm difference between the imaging isocenter and the machine isocenter (proton beam).Usually, this would not be an issue as this is within the normal day to day variation of what is acceptable.However, there are special cases, where the goal is to be <1mm in accuracy.Our medical professional would need to understand the clinical situation including the diagnosis, prescription, and the area being treated, as well as a composite plan of what was delivered versus what was planned to determine if there was a serious injury.Patient information has been requested from the site; however, they have declined to provide any further details.

• Brand Name: PROBEAM® PROTON VERSION 2.8
• Type of Device: PROBEAM® PROTON THERAPY SYSTEM
• Manufacturer (Section D): VARIAN MEDICAL SYSTEMS; 911 hansen way; palo alto CA 94304
• Manufacturer Contact: nia van baalen ; 911 hansen way; palo alto, CA 94304-1028 ; 6504246833
• MDR Report Key: 18472344
• MDR Text Key: 332391688
• Report Number: 2916710-2024-00001
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133191
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HGA0032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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