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 12/16/2022

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 field 2a was interrupted at 19.1 mu on (b)(6) 2022.However, the mosaiq alert states that 240.0 mu was delivered at the point of interruption.

Manufacturer Narrative

H4 updated.H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer is using mosaiq in conjunction with a third party product (adaptinsight from iba).The mosaiq logs have been reviewed and the investigation has found that mosaiq has recorded the data received.Mosaiq will record the highest value for the meterset that was received over the interface as the beam is being delivered which was 240 mus.Since the "current actual" rose to a value of 19.1 mus and never went past that value it is likely that 19.1 mus is the meterset that was delivered, however iba would need to confirm the meterset delivered since mosaiq logs do not contain this information.Elekta have contacted iba who will investigate the jump in real time measurements.Mosaiq did not have any malfunction and was working as designed and intended.There was no patient mistreatment as this was a recording issue.

• 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: 16371441
• MDR Text Key: 309514510
• Report Number: 3015232217-2023-00006
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.53
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 05/03/2023
• 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