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

Lot Number	VERSION 3.1.3.2
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	07/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that a hitachi treatment dose did not record in mosaiq.
Additional Manufacturer Narrative
D4: updated.H4: manufacturing date is not on the label, but it is known so field h4 has been completed with this information.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect but is not considered safety.The customer reported that a hitachi treatment dose did not record in mosaiq.It was determined that the computer connected to the treatment machine, which is referred to as the sequencer, received a "complete" state prematurely.The logs showed the sequencer had switched to a completion state while the treatment was still in progress on the particle machine.Mosaiq and the particle machine were out of sync and the treatment then had to be manually recorded.The treatment was successfully completed, but was not recorded in mosaiq.Mosaiq displayed a message to the user indicating that there was no recording.The user recorded the treatment manually.There was no patient mistreatment.This is a recording issue only and should the issue occur again, it would not result in patient harm as with the data from the machine log, the user (with help from our product support) would be able to verify the actual treatment and the treatment could be manually recorded.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawely, west sussex RH10 -9BL
• MDR Report Key: 20084569
• Report Number: 3015232217-2024-00026
• Device Sequence Number: 15353251
• Product Code: IYE
• UDI-Device Identifier: 07340201500026
• UDI-Public: (01)07340201500026(10)3.1.3.2
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203172
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2024

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?: Yes
• Operator of Device: Health Professional
• Device Lot Number: VERSION 3.1.3.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• 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