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 09/19/2023

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 that mosaiq recorded a treatment incorrectly.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer sent two fields with mu prescription of 130.0 and 23.0 respectively to the machine for treatment.The fields were treated but mosaiq recorded 260.0mu for first field and 0mu for the second field.The customer said that there was no error or interruption during the treatment.Based on the audit logs, mosaiq ran into an error while it was processing dicom beam records from truebeam.The 'loadbeamhistory' shows that there were two beam records for the first field and nothing for second field which explains why the first field was recorded twice.There was also a failure in the 'flushsegmentdatalist' which shows the error in the logs which contributed to the recording issue.This was a recording issue and did not reflect the real treatment since the dicom beam records show that all fields were treated fully and correctly.There was no patient mistreatment.It has not been possible to establish the root cause.This recording issue is detectable post treatment and does not affect or lead to patient mistreatment.Mosaiq detects this issue of the monitor units being delivered less than or more than the prescribed mu at the end of the session by displaying a message.If this message is ignored by the user, the next time the patient is treated, the treatment chart will display in 'red' indicating to the user that something mismatched as opposed to displaying black for a completed field.The 'red' will not only display on the session from the previous day but also for the future sessions until the chart is corrected to no longer having more or less monitor units.Mosaiq has multiple ways to mitigate a difference in the monitored units being received versus expected.If the initial message is received, the customer needs to verify the amount delivered via the dicom beam record or ask elekta for assistance.If the dicom beam record does not exist, the customer must request assistance from varian.

• 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; crawley, west sussex RH10 -9BL
• MDR Report Key: 17956794
• MDR Text Key: 325927324
• Report Number: 3015232217-2023-00064
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.84.002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2024

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: 09/19/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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