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

Device Problem Computer Software Problem (1112)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2023

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

Section h6 updated section h11 updated the investigation was completed by conducting a thorough evaluation of the product and the reported information the user followed an incorrect workflow to re-ct the patient during treatment.To re-ct the patient, the user should have created a second prescription & site setup in mosaiq's d&i (diagnosis and interventions) for the new reference ct to be imported to the second site setup which maintained the original data allowing treatment to continue under the newest prescription which leaves the previous cbct still attached to the older site setup.The site setup can only have one image associated.The user overwrote the original image by importing a new site setup which caused this issue to be seen.The older images are no longer under the original site setup as the user overwrote those with the wrong workflow.The root cause was determined to be use error.Mosaiq did not have any malfunction and was working as designed and intended.There was no patient mistreatment.

• 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: 18501261
• MDR Text Key: 332731583
• Report Number: 3015232217-2024-00005
• 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: 04/08/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 04/08/2024
• 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