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

Lot Number	VERSION 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	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a completion plan delivery error.
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.
Additional Manufacturer Narrative
H11 updated: the customer reported a completion plan delivery error.The investigation was completed by conducting a thorough evaluation of the products and the reported information.A treatment plan named adrptnnnadt06 was intended to be delivered on the day of the incident.The delivery of this plan was interrupted when a "beam interrupt" was experienced on the linac.A completion plan was attempted, this plan was called adrptnnncp06.Due to difficulties with patient set-up, this plan adrptnnncp06 was not delivered.Another version of this plan, called adrptnnnacp09 was created and used to deliver fields 2-5.Adrptnnnacp09 was created using optimize weights and shapes and ended up with slightly different mu than adrptnnncp06.However, the dose distributions are quite close and this plan is approved so it is assessed as being consistent with the intended delivery.Following this, fields 6-10 from adrptnnncp06 were delivered on another day, effectively completing the intended treatment.Elekta physics have assessed this incident and concluded that there was no mistreatment.The sum of the dose from all fields as treated is consistent with the original intended plan (i.E.Adrptnnnadt06) after accounting for user approved adaptation and completion plan variations.Based on available information there was no mistreatment.Mosaiq did not have any malfunction and was 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; crawely, west sussex RH10 -9BL
• MDR Report Key: 23377282
• Report Number: 3015232217-2025-00067
• Device Sequence Number: 15671377
• Product Code: IYE
• UDI-Device Identifier: 07340201500071
• UDI-Public: (01)07340201500071(10)3.2.2.0
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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 3.2.2.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 11/19/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown