MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MOSAIQ; MOSAIQ ONCOLOGY INFORMATION SYSTEM

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/29/2023
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.
Event or Problem Description
Customer reported that after treatment the recorded beams were not recorded in mosaiq.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The investigation found that according to machine and audit logs, a field was entered for treatment verification and the machine transitioned to a ready state.However, there was no indication of a beam on state in the logs for this field so the treatment to the field could not be validated from these logs.Review of the sdd logs has confirmed that the prescribed dose of 361.5 mu was successfully delivered to the field which the customer manually recorded.There was no patient mistreatment.Based on the information provided, there was no product malfunction and mosaiq is working as designed and intended.Mosaiq did not receive data from the linac to indicate that the beam was being delivered.As a result, mosaiq did not record a treatment for the field.Mosaiq can only record according to what it receives from the machine.
Additional Manufacturer Narrative
H11 additional information.This is a follow-up to the final report submitted on 26 april 2024 to notify that due to an administrative error this case was submitted under an incorrect mfr report number (3015232-2024-00006) which captured the wrong manufacturer information.An initial and final (combined) report was submitted under the correct mfr number (see report 2950347-2024-00003) with the correct manufacturer.

• Brand Name: MOSAIQ
• Common Device Name: MOSAIQ ONCOLOGY INFORMATION SYSTEM
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• 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: 18586409
• Report Number: 3015232-2024-00006
• Device Sequence Number: 8246751
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.294
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2024

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 04/26/2024; 07/05/2024
• 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