MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MOSAIQ; MOSAIQ ONCOLOGY INFORMATION SYSTEM

Device Problem Computer Software Problem (1112)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2023

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

Customer reported that after treatment the recorded beams were not recorded in mosaiq.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The investigation found that according to machine and audit logs, a field was entered for treatment verification and the machine transitioned to a ready state.However, there was no indication of a beam on state in the logs for this field so the treatment to the field could not be validated from these logs.Review of the sdd logs has confirmed that the prescribed dose of 361.5 mu was successfully delivered to the field which the customer manually recorded.There was no patient mistreatment.Based on the information provided, there was no product malfunction and mosaiq is working as designed and intended.Mosaiq did not receive data from the linac to indicate that the beam was being delivered.As a result, mosaiq did not record a treatment for the field.Mosaiq can only record according to what it receives from the machine.

• Brand Name: MOSAIQ
• Type of Device: MOSAIQ ONCOLOGY INFORMATION SYSTEM
• 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: 18586409
• MDR Text Key: 333838412
• Report Number: 3015232-2024-00006
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.294
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/26/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2019
• 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