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

Lot Number	3.2.2.0
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	05/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H4: manufacturing date is not on the label, but it is known so field h4 has been completed with this information.H11: the manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that the 'actual' values displayed in site setup did not match with the 'actual' values displayed on integrity.
Additional Manufacturer Narrative
H11 updated: the customer reported that the 'actual' values displayed in site setup did not match with the 'actual' values displayed on integrity.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The mosaiq logs show that on 03 may 2025, field a1 was selected, and site setup verification was entered.The couch move assistant window was manually opened and prescribed offset shifts were successfully applied to the "start" values in cma to reach the "target" couch values.After the targets were achieved, no new couch positions were reported in the logs before the user overrode the "couch vertical actual" and "couch lateral actual" values that were displayed in site setup.These values are close to the starting couch positions prior to applying shifts and no unusual behavior was found in the logs to suggest why the couch actuals in site setup were not updating to current values.Once site setup was completed and the treatment field was loaded, the actuals presented in "treatment field verification" correctly reflected the current couch positions which still matched the intended targets for couch.The fields were treated, and based on the available information, there was no patient mistreatment.When the actual couch value in site setup verification do not automatically refresh with the new value from couch move assist, the user is alerted by the field being flagged in red.This shading alerts the user that the value is out of tolerance and must be corrected or overridden prior to continuing verification steps.These safety mitigations performed as expected.Elekta believes that a glitch happened during site setup which prevented updates to the couch actuals displayed in that window.The glitch cannot be explained as nothing abnormal was captured in the logging during that period.The actual root cause cannot be determined.Mosaiq did not have any malfunction and is working as designed and intended.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL,
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• 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: 22122364
• Report Number: 3015232217-2025-00019
• Device Sequence Number: 7175431
• Product Code: IYE
• UDI-Device Identifier: 07340201500071
• UDI-Public: (01)07340201500071(10)3.2.2.0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K223229
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2025

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: 3.2.2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown