MAUDE Adverse Event Report: MEVION MEDICAL SYSTEMS, INC. MEVION S250; PROTON THERAPY DEVICE

Device Problems Computer Software Problem (1112); Loss of Data (2903); Device Operates Differently Than Expected (2913); Application Program Problem: Medication Error (3198)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 11/22/2016

Event Type  malfunction  

Manufacturer Narrative

Device was not returned to manufacturer.

Event Description

This notification reports a malfunction and adverse event.A software error has been identified wherein patient position corrections are lost when using multiple setup field plans to treat at multiple isocenters in sequence resulting in lost deltas when closing a setup field.A software error or other user condition can occur in the few milliseconds after the first setup field is closed and before the information is communicated back to the record and verify system.One mistreatment occurred whereby a single treatment fraction was delivered approximately 3 cm from the target area.The single treatment was more than 2 cm from the prescribed field edge, thus meeting the definition of a "serious injury".The product software shall be updated to resolve the issue and prevent recurrence of the event.

• Brand Name: MEVION S250
• Type of Device: PROTON THERAPY DEVICE
• Manufacturer (Section G): MEVION MEDICAL SYSTEMS, INC.; 300 foster street; littleton MA 01460
• Manufacturer Contact: thomas faris ; 300 foster street; littleton, MA 01460 ; 9785401500
• MDR Report Key: 6202289
• MDR Text Key: 63617081
• Report Number: 3007087027-2016-00003
• Device Sequence Number: 1
• Product Code: LHN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120676
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/23/2016

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?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/26/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other