MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Event Description

The customer reported a treatment field issue and the mu has been exceeded.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.According to the software logs, two fields were selected for delivery using consolidated field sequencing (cfs).The machine was set to deliver the two fields as a single beam for a total of 196.9 mu.A "fine pot offset x2" error occurred after 158.3 mu had been given.At this point, the first field was fully treated, and the second field received 56.4 mu of its prescribed 95.0 mu leaving a remainder of 38.6 mu to be delivered to the second field.The machine was set to deliver the remaining 38.6 mu, however another "fine pot offset x2" error was encountered after a beam on state was detected, but 0 mu were received from the machine as delivered.After this, there was a machine communications time out and an abnormal termination message was noted.Mosaiq displayed '0 mu' on the abnormal termination form which provided three choice options to the user: 1) the treatment information is correct.Record the treatment.2) monitor units were delivered, but the value is not correct.Manually record the treatment.3) no monitor units were delivered.Exit the field and do not record the treatment.The user selected the second option to correct the treatment chart and accidentally entered an incorrect value for the manual recording of the second field.The full recording of the first field and the partial delivery of 56.4 mu for the second field were correctly recorded in mosaiq.Mosaiq did not have any malfunction and is working as designed and intended.The incorrect manual recording of the second field is due to use error.When the treatment was interrupted, the patient received an underdose of 38.6 mu from a single field of a two-field treatment plan.The intended dose from the field was 90 cgy and the total intended mu from the field was 95 mu.The total intended daily dose was 180 cgy and the total number of fractions is 23 so that the total overall treatment dose is 4140 cgy.Assuming no corrective action was taken, and the missing dose was ignored this would represent an underdose of ~20% on the day of treatment or ~0.9% over the course of the treatment.Elekta physics assessed this as an insignificant radiation underdose.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawely, west sussex RH10 -9BL
• MDR Report Key: 18452697
• MDR Text Key: 332738655
• Report Number: 3015232217-2024-00003
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1