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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 04/05/2023

Event Type  malfunction  

Event Description

The customer reported that the images recorded/stored in mosaiq are not related to reference computerised tomography (ct)/ cone beam computed tomography (cbct).

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

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
• Type of Device: 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
• MDR Text Key: 314622852
• Report Number: 3015232217-2023-00028
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002336
• UDI-Public: (01)00858164002336(10)2.82.108
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/05/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1