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

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 07/26/2023

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 crashed.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that mosaiq crashed.The investigation found from the machine, audit and itcsm logs that for the treatment session fields a:tx b:tx c:tx d:tx e:tx f:tx g:tx were sent to the machine.In this session, mosaiq received six dicom beam records for all fields except there was no beam record for field g.From the machine logs it was ascertained that mosaiq did not crash but that it was correctly rebooted (with unloaded).Despite field g that had not been treated the user proceeded to exit the treatment session.The user then selected field g and manually recorded that the field was partially treated for 126mu out of 259mu.It is unclear where 126mu came from as it was not seen in the logs or beam records.The customer should check with the supplier of the linac to confirm whether field g was treated in full or partially treated.With the information provided, this is use error as the customer did not complete the whole treatment for field g.Based upon the available information elekta have performed a severity analysis that if the dose was not fully delivered this would have been a negligible radiation underdose.Elekta has been unable to determine the root cause as to why field g beam records were not sent to mosaiq.Mosaiq did not have any malfunction and was working as designed and intended.

• 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: 17622332
• MDR Text Key: 321930205
• Report Number: 3015232217-2023-00048
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.053
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2023

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
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 07/26/2023
• Supplement Dates FDA Received: 11/24/2023
• 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