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

Lot Number	VERSION 2.84.011
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a problem sending table parameters from monaco to mosaiq.
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.
Additional Manufacturer Narrative
H2 updated.H6 updated.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported a problem sending table parameters from monaco to mosaiq.It was ascertained that when the plan was being promoted into mosaiq, warnings were presented to alert the user that inconsistent isocenter positions were found in the plan.Due to this inconsistency, zero isocenter values were assigned to the reference structure set/isocenter in site setup definition after the plan was imported.The user would need to update the site setup definition with the desired isocenters or replan.The user did not edit the zero isocenter values and incorrectly used them as the reference for patient positioning for the treatment delivered.Elekta physics have assessed this as a non-serious radiation overdose.The root cause was determined to be use error.Mosaiq did not have any malfunction and worked 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: 22140573
• Report Number: 3015232217-2025-00021
• Device Sequence Number: 7122550
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.84.011
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2025

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?: Yes
• Operator of Device: Health Professional
• Device Lot Number: VERSION 2.84.011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown