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	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
In the event that a user action causes isocenter to be lost during the setup workflow, the system will present error messages on the in-room monitor and the tc screen indicating that deltas were not applied during setup or a program move complete (pmc) was not achieved.When the setup field is closed another error message appears on the tc that informs the user of a problem, which they must correct.The user is prevented from proceeding to a treatment field until the setup is corrected and the setup field is closed with a pmc.The auto-field sequencing option as currently implemented, automatically loads the first treatment field after the above error message is acknowledged.The workflow is permitted to proceed to treatment.Additional warnings will appear before each beam can be turned on, but those warnings may be improperly ignored.If the incomplete move and lost isocenter puts the patient a significant distance away from the prescribed position, a misadministration due to a geographic miss is possible.

• 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: 10787991
• Report Number: 3007087027-2020-00007
• Device Sequence Number: 11806741
• 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): 11/03/2020

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: 10/05/2020
• Initial Report FDA Received Date: 11/04/2020
• 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