• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEVION MEDICAL SYSTEMS, INC. MEVION S250 PROTON THERAPY DEVICE Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEVION S250
Type of DevicePROTON 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 Key6202289
MDR Text Key63617081
Report Number3007087027-2016-00003
Device Sequence Number1
Product Code LHN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120676
Number of Events Reported1
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
Date FDA Received12/23/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2016
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/26/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/23/2016 Patient Sequence Number: 1
-
-