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 Patient Problem/Medical Problem (2688)

Event Date 04/24/2020

Event Type  malfunction  

Event Description

Near miss associated with a software defect.Therapist discovered issue prior to commencing treatment.Reported as mdr to risk of mistreatment in case of recurrence.Customer reported a near miss that occurred during patient positioning setup for treatment.During setup, the radiation therapist noted that one of the couch correction elements (couch pitch) was not communicated and corrected.The customer detected the failure to correct couch position and did not execute treatment.The missing correction was caused by a software defect: using verity with a single planar image will deselect degrees of freedom (dof) which are not determinable by the acquired image, or a user may manually deselect any of the dof by unchecking the boxes next to the axis.If a 3d ct or cbct scan is then acquired and used for 6 dof alignment there is a small probability that the couch correction widget will retain the unchecked axis state from the previous image registration.If the user fails to notice the verity widget has unchecked boxes, ignores the dialog on verity that indicates which moves are being sent to the couch, and also fails to notice that the in room monitor is only showing some of the intended corrections, then it is possible that the couch will not execute all the intended movements and the patient will be misaligned.The customer believes that has occurred a few times and likely has resulted in a geometric error of up to 1.5 cm (for a single fraction only).This is of negligible medical severity, but could potentially recur and result in an offset of up to 2 cm.

• Brand Name: MEVION S250I
• Type of Device: MEVION PROTON RADIATION THERAPY SYSTEM
• Manufacturer (Section D): MEVION MEDICAL SYSTEMS, INC.; 300 foster street; littleton, ma
• Manufacturer (Section G): MEVION MEDICAL SYSTEMS, INC.; 300 foster street; littleton, ma
• Manufacturer Contact: thomas faris ; 300 foster street; littleton, ma ; 5401500
• MDR Report Key: 10145357
• MDR Text Key: 194975543
• Report Number: 3007087027-2020-00005
• Device Sequence Number: 1
• Product Code: LHN
• 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: Other
• Type of Report: Initial
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• 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: 04/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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