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

Model Number	MEVION S250I
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: MEVION PROTON RADIATION THERAPY SYSTEM
• Manufacturer (Section D): MEVION MEDICAL SYSTEMS, INC.; 300 foster street,; littleton MA 01460
• MDR Report Key: 10719879
• Report Number: 3007087027-2020-00006
• Device Sequence Number: 16922075
• Product Code: LHN
• UDI-Device Identifier: 00864366000124
• UDI-Public: (01)00864366000124(11)181219
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K172848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MEVION S250I
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other