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

Lot Number	VERSION 2.81.070
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	12/18/2024
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.
Event or Problem Description
Customer reported incorrect values recorded in patient's treatment chart.
Additional Manufacturer Narrative
H6 updated.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.On 18 december 2024, 4 fields were sent to the machine for treatment.The machine logs confirm that all 4 fields were treated correctly in full, however the values recorded in the treatment chart did not match.There was no mistreatment of this patient.It has been identified that the issue is caused by a software defect.The defect has been assessed as non-safety.This is a recording issue only, though it may cause confusion, it would not result in patient mistreatment.The defect will be fixed in a future release of mosaiq.Additionally, elekta has requested to the customer that a diagnostic utility record (dur) is installed at the customer's site to monitor the device, and capture further information should it re-occur.

• 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: 21178841
• Report Number: 2950347-2025-00006
• Device Sequence Number: 17199217
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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?: No
• Operator of Device: Health Professional
• Device Lot Number: VERSION 2.81.070
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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