MAUDE Adverse Event Report: ELEKTA INC 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 03/22/2023

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

The customer reported an issue with treatment field definition related to couch capture function in mosaiq.

Manufacturer Narrative

H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported an issue with treatment field definition related to couch capture function in mosaiq and that during edit the beam energy changed.The customer informed that the discrepancy was identified during the read through of beam parameters prior to treatment.The energy was converted back to the correct value and the treatment was delivered.Review of the logs have ascertained that the data shows that a capture was performed for field 1.However, there is no indication in the logs that capture couch only was performed on field 2 which was reported to have had a change to couch angle on that date following capture couch only.The logs show that couch copy was used to copy couch values from field 1 to field 2 as well as some other fields.Shortly after this, field 2 was selected for treatment and the couch values copied from field 1 were the new prescribed values for field 2.There was no patient mistreatment.Elekta have thoroughly reviewed the code for couch capture only and have concluded that the code design could not have resulted in an inadvertent change to energy or couch angle.Moreover, no changes to energy or couch angle were seen during in-house testing of the couch capture only function.There was no product malfunction and mosaiq is working as designed and intended.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): ELEKTA INC; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 16775727
• MDR Text Key: 313642565
• Report Number: 2950347-2023-00002
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.167
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141572
• 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: 07/17/2023

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: 03/22/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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