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

Device Problem Computer Software Problem (1112)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

The customer reported that the session dose does not match the session.

Manufacturer Narrative

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

Manufacturer Narrative

The customer contacted elekta with questions as to why the recorded dose in mosaiq was occasionally red (dose mismatch warnings) and why the fraction count in mosaiq does not always match epic.Epic is an ehr (electronic health record system).In the information provided by the customer, sessions 2 and 5 of the prescription ltpelvis are red and there is no value in the fx column (fraction count).An investigation concluded that the mosaiq dosimetry configuration fractions calculation value was configured to be 90%.Looking at the delivered dose for the session, it was determined that the amount was less than the configured 90% so mosaiq did not count that as a fraction.Since mosaiq did not count this as a fraction, the column was 0.Since the percentage was less than the configured 90%, it was shaded red as a warning.Mosaiq is working as designed in this scenario.This might also be the cause of the fraction mismatches between mosaiq and epic.To prevent the fraction count issue from happening as much, the customer can change the fractions calculated percentage from 90% to 85% in the mosaiq departments dosimetry configuration.It is also possible to change this setting for a specific rx (prescription).This customer has set their verification tolerances, to 5%.The main purpose of this is to let the user have some control over when there is a warning regarding a fraction dose mismatch.For the information provided, the dose percentage difference is 11.6%, which is greater than the configured 5%.As such mosaiq would display an fx dose mismatch warning in the treatment readiness check and the available treatment chart session would also show in red in the dly (daily dose) column.Based on available information there was no mistreatment.Mosaiq is working as designed in this scenario.

• 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: 17389319
• MDR Text Key: 320423532
• Report Number: 3015232217-2023-00043
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.040
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

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: 06/26/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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