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 12/04/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that a qa patient recorded 2fff energy instead of 6fff.

Manufacturer Narrative

Section h6 updated.Section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.On 4th december 2023, the customer sent five fields for port field to the machine's cloud environment for treatment.All fields were defined with 6fff energy, but mosaiq recorded these as 2fff energy.This was noticed by the user during a test patient.From the dicom beam records received from the machines on (b)(6) 2023, all records have the dicom tags for fff and the energy of 2.5.Mosaiq doesn't allow decimal point for energy, thus mosaiq recorded 2.5 as 2 and this is why mosaiq recorded the energy of 2fff for the fields.From the dicom beam records received from the varian machine on 6th december 2023, all fields have the energy of 6fff and two fields have the dicom tags for fff.The recording of 2fff energy for fields treated on (b)(6) 2023 and the recording of 6fff energy on (b)(6) 2023 were according to what was received in the beam records from the machine.Mosaiq did not have any malfunction and is working as designed and intended since it can only record what was received from the varian machine (without the decimal point).The customer was advised to contact varian to investigate why these fields were sent back with the energy of 2.5 fff.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: 18454500
• MDR Text Key: 332729600
• Report Number: 3015232217-2024-00001
• Device Sequence Number: 1
• Product Code: IYE
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/24/2024

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: 12/06/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• 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