MAUDE Adverse Event Report: ELEKTA INC MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Model Number	MOSAIQ
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an issue with treatment field definition related to couch capture function in mosaiq.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
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.It was ascertained from the log files that the user made changes to the "treatment field definition" which were noted in the delta window.The user has to accept the changes.The change to energy is believed to have happened after the treatment field definition was opened for edit and outside of the couch copy only feature, yet the separate actions happened to correlate with each other.The energy was corrected prior to treatment delivery so there was no mistreatment.Changes to the treatment field definition were noted in the field delta window that was shown to the customer.The user has to accept or reject the changes in the field delta before treatment so this is detectable prior to treatment.The issue was due to use error.There was no product malfunction and mosaiq is working as designed and intended.

• Brand Name: MOSAIQ
• Common Device Name: 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: 16775463
• Report Number: 2950347-2023-00001
• Device Sequence Number: 15158555
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.167
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K141572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2023
• Supplement Date Received by Manufacturer: 03/22/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown