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 07/21/2023

Event Type  malfunction  

Event Description

The customer reported an incorrect recording in mosaiq.

Manufacturer Narrative

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

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the report information.The customer reported an incorrect recording in mosaiq.According to the logs a field was entered and the treatment ended when a "delivery mismatch" machine error occurred.Mosaiq received a count of 542.2 mu from the machine as having been delivered which was processed and recorded by mosaiq.As mosaiq can only record the data that it receives from the machine there was no malfunction and mosaiq worked as designed and intended.On this occasion, it was not possible to retrieve the system diagnostic data (sdd) files covering the date of the incident to further investigate the details of the incident and identify the root cause.The customer verified that 141 mu was given based on the bmdm readout.Elekta physics have assessed that in the worst case scenario, if the error remains unaccounted for and this represents an underdose of ~75% on the day of treatment and ~3% over the total course of treatment this would be a negligible radiation underdose.

• 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; crawely, west sussex RH10 -9BL
• MDR Report Key: 17570393
• MDR Text Key: 321410536
• Report Number: 3015232217-2023-00047
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.025
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 07/21/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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