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	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation is completed.
Event or Problem Description
The customer reported that the treatment dose was not recorded in mosaiq.
Additional Manufacturer Narrative
G4:updated h4: manufacturing date is not on the label, but it is known so field h4 has been completed with this information.H11 updated: the customer reported that the treatment dose was not recorded in mosaiq.The investigation was completed by conducting a thorough evaluation of the products and the reported information.Field a was sent to the machine for treatment, with an intended dose of 120mu.During the treatment there was an interruption, and then it was continued to completion.At the end of the treatment mosaiq received two beam records for this field.One of the beam records was for the partial treatment of 119mu before the interruption, and the second beam record was for the <1.0mu that was delivered after the interruption.Mosaiq incorrectly processed the second beam record and recorded it as 0.0mu.Thus, field a was recorded only as 119.0 mu.The customer already manually recorded an extra 1.0mu for field a.There was no patient mistreatment.It has been identified that this issue was caused by a software defect in mosaiq whereby, when a technical issue interrupts a truebeam treatment and then the treatment is continued, mosaiq correctly records two beam records but the continuation record is incorrectly recorded as 0mu instead of 0.Xmu.This only occurs when the delivered mu is <1mu.A delivery error of <1.0mu is <1% in any treatment scenario, this is considered insignificant.Elekta performed a risk assessment and assessed the severity of harm to be "insignificant" and probability to be "implausible".The risk assessment concluded that the risk is considered low.The defect will be fixed in a future release of mosaiq.
Additional Manufacturer Narrative
D4 updated.The version number was in the incorrect field, this has been corrected.

• 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: 21991895
• Report Number: 3015232217-2025-00013
• Device Sequence Number: 20952272
• Product Code: IYE
• UDI-Device Identifier: 07340201500071
• UDI-Public: (01)07340201500071(10)3.2.2.0
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2025

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 3.2.2.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 06/20/2025; 06/24/2025
• 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