The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported a discrepancy between the treatment fields' parameters in mosaiq and the imported plans.Elekta used the same plan in-house provided by the customer to evaluate import processing and found that plan promotion works as expected.The parameter values (e.G., gantry, collimator, field size, etc.) in mosaiq matched those of the plan.Once promoted, the plan is in a pending state and values can be changed without version roll until the plan has been approved or treated.From the logs it was determined that changes by the user from the original plan occurred after the initial plan was imported and were accepted by the user.Based upon information available elekta physics have assessed that the patient received an underdose which is considered non-serious.A single field was delivered with the incorrect beam geometry on a single day of treatment and then treated partially on a second day of treatment.During the partially incorrect delivery, the beam was delivered with the incorrect geometry.This error in dose was (b)(4) over the course of the entire treatment.Mosaiq did not have any malfunction and worked as designed and intended.The issue was due to use error.
|