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

Model Number	MOSAIQ
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the images recorded/stored in mosaiq are not related to reference computerised tomography (ct)/ cone beam computed tomography (cbct).
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
An investigation was attempted by conducting an evaluation of the product and the reported information.The customer reported that the images recorded/stored in mosaiq are not related to reference computerised tomography (ct)/cone beam computed tomography (cbct).The customer was contacted multiple times in order to obtain the required information and logs for the investigation to continue.However, the customer did not respond to these requests.This customer is using mosaiq outside of the available software's functionalities during attempted 'adaptive-treatment situations'.Mosaiq is not malfunctioning with all the current available functionalities per instructions for use (ifu) operating as intended.The user is operating mosaiq outside the ifu of the device for normative usage protocols where this reported situation occurred.Future elekta one software from elekta will eventually have this desired software feature/functionality for adaptive treatment management interacting with mosaiq.This desired adaptive treatment functionality is in development based on customer feedback on increasing adaptive-treatments and suggestions for device improvements.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• 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: 16874663
• Report Number: 3015232217-2023-00028
• Device Sequence Number: 5830078
• Product Code: IYE
• UDI-Device Identifier: 00858164002336
• UDI-Public: (01)00858164002336(10)2.82.108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2024

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
• Device Model Number: MOSAIQ
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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