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 10/05/2020

Event Type  malfunction  

Event 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
• 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: 10787991
• MDR Text Key: 214784245
• Report Number: 3007087027-2020-00007
• 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: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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: 10/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2018
• 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