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

Lot Number	VERSION 2.83.040
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	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported partial treatment plan not loading.
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
Section d3: updated the address.Section d4: lot number updated to 2.83.040.Udi number updated.Section h4: updated.Section h6: updated.Section h11: updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that a field was partially treated and recorded.The user was unable to complete this partial treatment due to an error.The investigation found that mosaiq prevented the user to continue the treatment by sending the following message: "index was out of range.Must be non-negative and less than the size of the collection.Paramter name: index" as well as "unable to send plan to the machine.Unable to load the plan into rtobjects." the treatment records were reviewed and concluded that there was no patient mistreatment.Elekta was unable to reproduce the issue internally with the data provided by the customer.Mosaiq did not have any malfunction and was working as designed and intended as the software prevented the user from continuing treatment with the error that occurred and correctly recorded the dose.

• 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: 21157372
• Report Number: 2950347-2025-00002
• Device Sequence Number: 8433630
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.040
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 01/29/2025

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 2.83.040
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2021
• 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