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

Lot Number	VERSION 2.84.002
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.H4: manufacturing date is not on the label, but it is known so field h4 has been completed with this information.
Event or Problem Description
The customer reported that cbct (cone beam computed tomography) was not recorded in mosaiq.
Additional Manufacturer Narrative
D3 updated: initial report submitted with an incorrect address.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that cbct (cone beam computed tomography) was not recorded in mosaiq.This issue would not result in patient harm and is not a safety issue.It was ascertained that image registration was performed and accepted before treatment, however a record of the cbct was not recorded in mosaiq, as truebeam (third party product) does not send back the ct record.Mosaiq would gather data and keep track of the cbct.Usually, mosaiq would receive the cbct, structure set and sro files in order from the machine and successfully create a ct record for the session.In some instances, these files can be sent back in a different order from the machine due to the latency of the network or to a delay in creating/sending from the machine.In these instances, most of the time with the data received, mosaiq would resolve and successfully create a ct record.However, sometimes mosaiq would not be able to resolve and fails to create a ct record.All treatment fields were delivered and recorded correctly and based on available information there was no patient mistreatment.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL,
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter centre terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 21157749
• Report Number: 2950347-2025-00003
• Device Sequence Number: 7573772
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.84.002
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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
• Operator of Device: Health Professional
• Device Lot Number: VERSION 2.84.002
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown