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 12/12/2022

Event Type  malfunction  

Event Description

The customer reported intermittent mosaiq error messages on linac sequencer.

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 intermittent mosaiq error messages on linac sequencer.It was ascertained from the mosaiq logs that the cause of the clientvmi and com call failed messages encountered by the customer as well as the patient mismatch whilst selecting the next patient appears to be the result of communication/network issues which produced an inconsistent state.Mosaiq did not have any malfunction and is working as designed and intended.Based on the available information there has been no 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: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 16131441
• MDR Text Key: 307511362
• Report Number: 3015232217-2023-00000
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.40
• 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: 08/02/2023

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
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/10/2023
• Supplement Dates Manufacturer Received: 12/12/2022
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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