MAUDE Adverse Event Report: MEVION MEDICAL SYSTEMS, INC. MEVION S250I; MEVION PROTON RADIATION THERAPY SYSTEM

Model Number MEVION S250I

Device Problem Computer Software Problem (1112)

Patient Problem Erythema (1840)

Event Date 09/24/2020

Event Type  malfunction  

Event Description

Customer reported upon initiation of a treatment beam, the treatment console (tc) screen unexpectedly terminated the beam and blanked out the current field delivery information.The monitor unit (mu) counter on the top right of the tc screen continued to increment up, and the beam control box continued to emit beeping sounds consistent with beam delivery.No dicom record for that beam was created or sent to the oncology information system (ois), and the records accessible to the users showed no delivery of dose to that field.This left the therapist and physicist uncertain as to how much beam was delivered.Had the users decided to deliver the same beam again the patient could be over treated.The hardwired monitor unit counter (hmuc) located in the system cabinet accurately captured the dose delivered but was not recorded before a subsequent user action cleared that counter.

• Brand Name: MEVION S250I
• Type of Device: MEVION PROTON RADIATION THERAPY SYSTEM
• Manufacturer (Section D): MEVION MEDICAL SYSTEMS, INC.; 300 foster street,; littleton MA 01460
• Manufacturer (Section G): MEVION MEDICAL SYSTEMS, INC.; 300 foster st; littleton MA 01460
• Manufacturer Contact: morris bellows ; 300 foster st; littleton, MA 01460 ; 9785401500
• MDR Report Key: 10719879
• MDR Text Key: 241258934
• Report Number: 3007087027-2020-00006
• Device Sequence Number: 1
• Product Code: LHN
• UDI-Device Identifier: 00864366000124
• UDI-Public: (01)00864366000124(11)181219
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K172848
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEVION S250I
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2020
• 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): Other