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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

The customer reported that when reviewing the patient's image the 2d image review window displays the image from the previous patient.

Manufacturer Narrative

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

Manufacturer Narrative

B1 updated h2 updated h6 updated h10 updated the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that when reviewing the patient's image the 2d image review window displays the image from the previous patient.It was ascertained from the mosaiq log files that there was no mistreatment to both of the patients.The incorrect display of the image did not affect the treatment to both patients.This is a display issue and it has no effect on the treatment and recording of the selected patient.This would not cause patient harm since it only impacts display of the historic record after treatment delivery and not the actual record.It would not result in a poor clinical decision that would lead to a safety issue.Elekta has been unable to replicate the issue or determine the root cause of the display issue.A diagnostic utility record (dur) to collect data was provided to the site to facilitate the investigation, however the issue has not reoccurred.The customer is now upgrading to mosaiq 3.0, so the investigation can no longer continue as the 2d image workflow in mosaiq 3.0 would not encounter this issue.

• 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: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 16551569
• MDR Text Key: 311531121
• Report Number: 3015232217-2023-00007
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.053
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/16/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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