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 10/04/2023

Event Type  malfunction  

Event Description

The customer reported discrepancies in the treatment historical record.

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 reported information.The customer reported that they found discrepancies in the treatment historical record for all the treatment fields.The customer discovered during qa that the multi leaf collimator (mlc) values were not recorded as expected and that the x & y jaws were inverted when sent to the treatment machine.This issue was found to be a recording problem of the mlc values.It is suspected that the initial install of mosaiq was not completed according to the installation procedures, specifically the configuration of the mac and cfg values; however, the original configuration was accepted by the customer.Software installation procedure testing was not carried out as part of the installation and acceptance activities with the customer.The root cause was due to configuration of the mac and cfg; this is a recording issue and did not lead to patient harm.Upon reporting the issue to elekta corrections have been made to the mac and cfg and the customer eventually resolved the issue.The new configuration was accepted and signed off.Mosaiq did not have any malfunction and worked as designed and intended.Based on the available information 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: 18046488
• MDR Text Key: 327043478
• Report Number: 3015232217-2023-00067
• 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: SN
• 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: 11/29/2023

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: 10/04/2023
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 10/04/2023
• Supplement Dates FDA Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• 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