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

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	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that not all fields recorded in mosaiq - patient (b)(6).
Additional Manufacturer Narrative
H4: manufacturing date is not on the label, but it is known so field h4 has been completed with this information.The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.Note: the customer reported the same issue, but for 2 separate patients.Patient b has been reported under: 3015232217-2025-00011.
Additional Manufacturer Narrative
H11 updated: the customer reported that not all fields recorded in mosaiq - patient a.The investigation was completed by conducting a thorough evaluation of the products and the reported information.Field 1arc1 was entered for treatment verification.Based on the information captured in the logs, there appears to be a breakdown of the data transfer between vmi_icom and vmi_main in mosaiq.In this event, vmi_main did not receive a "beam on" state status from vmi_icom.Notification of "beam on" in vmi_main is required by mosaiq for a treatment delivery recording to be processed, and that notification is missing in this instance.The customer knows that field 1arc1 was fully treated by the linac and has already entered a manual recording.There was no patient mistreatment.Further investigation found active entries in the machine.Cfg file for an apex unit which the customer has confirmed is no longer in use.The logging generated with the apex configuration enabled random irregularities in the data received for beam on activities.The old machine.Cfg where apex was enabled with the non-existent apex unit was interfering with the receipt of "beam on" state notification on occasion.This is a recording problem caused by an identified customer's machine configuration issue.Since this obsolete device configuration was removed, the issue has not reoccurred.There was no product malfunction.Mosaiq was working as designed and intended.Note: the customer reported the same issue, but for 2 separate patients.Patient b has been reported under: 3015232217-2025-00011.

• 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: 21941110
• Report Number: 3015232217-2025-00010
• Device Sequence Number: 9121988
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.040
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/03/2025

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: 04/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 07/03/2025
• 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