MAUDE Adverse Event Report: ELEKTA INC MOSAIQ; MOSAIQ ONCOLOGY INFORMATION SYSTEM

Lot Number	VERSION 2.64.296.0001
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	10/11/2024
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.Please note this case is for the second patient.The first patient is addressed in (b)(4) (2950347-2024-00011).
Event or Problem Description
Customer reported chart check showing overrides.
Additional Manufacturer Narrative
B3: updated h11 updated: customer reported chart check showing overrides.The investigation was completed by conducting a thorough evaluation of the product and the reported information.On (b)(6) 2024, field 2b was sent to the machine and treated in full.Mosaiq incorrectly displayed the actual mu in both the override report and the header section of the treatment chart window for the field.This incorrect recording was caused by the erroneous specified meterset value ((b)(6) instead of (b)(6)) recorded in the beam record from the third-party machine that mosaiq received and used.The field, however, was treated in full and recorded correctly in the treatment history report.There was no mistreatment of field 2b for this patient.The defect was resolved in mosaiq (b)(6) which was available from (b)(6) 2021.The customer is using mosaiq 2.64.296.0001, this version is end of life and no longer supported.The customer is planning an upgrade to a newer version of mosaiq.Please note this case is for the second patient.The first patient is addressed in (b)(4).(2950347-2024-00011).

• Brand Name: MOSAIQ
• Common Device Name: MOSAIQ ONCOLOGY INFORMATION SYSTEM
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• 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: 20695278
• Report Number: 2950347-2024-00012
• Device Sequence Number: 17089457
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.296.0001
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K141572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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 2.64.296.0001
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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