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

Model Number MEVION S250

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Pain (1994)

Event Date 08/23/2016

Event Type  Injury  

Event Description

During patient setup, a radiation therapist failed to note the distance between the treatment machine applicator (the delivery head of the treatment machine) and the treatment table and pinched her finger between the applicator and the treatment table.As the applicator approaches the treatment area, it enters a slow mode of movement to prevent injuries.The therapists are trained and warned in the instructions for use to carefully monitor applicator position when moving it into treatment location.

• Brand Name: MEVION S250
• Type of Device: MEVION S250 PROTON THERAPY SYSTEM
• Manufacturer (Section D): MEVION MEDICAL SYSTEMS, INC.; 300 foster street; littleton MA 01460
• 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: 6249580
• MDR Text Key: 64779264
• Report Number: 3007087027-2017-00004
• Device Sequence Number: 1
• Product Code: LHN
• UDI-Device Identifier: 00864366000100
• UDI-Public: (01)00864366000100(11)150526
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEVION S250
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention