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

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	08/17/2023
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 a discrepancy between the numerical table shift in mq and the visual match.
Additional Manufacturer Narrative
Section h6 updated.Section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.A number of fields were sent to the truebeam machine for treatment, these fields contained couch shift values.Because the fields contained couch shift values, truebeam asked the user to move the couch back to centre prior to taking the cbct to prevent the gantry colliding with the couch.The user centred the couch and then took two cbcts.Truebeam does not create a ct record by design, therefore mosaiq needed to compensate by creating that ct record itself using the positions from one of the slides from the above mentioned cbcts.This means the couch positions recorded for the ct record are as per where the couch was when the cbct was taken - in this case centred.The original couch shifts were then applied to the fields and the restore couch was performed to move the couch back to the intended treatment position, and the treatment fields were treated at this couch position.Both mosaiq and the beam records confirm this.Mosaiq did not have a malfunction and was working as designed and intended.There was no mistreatment of the patient.

• Brand Name: MOSAIQ
• Common Device Name: 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: cornerstone; london road; crawley, west sussex RH10 -9BL,
• MDR Report Key: 18038696
• Report Number: 3015232217-2023-00065
• Device Sequence Number: 8398210
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K183034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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