MAUDE Adverse Event Report: ELEKTA INC 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)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer requested help on how to handle lag between sessions and dose accumulation in mosaiq monitoring.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H2 updated.H6 updated.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer requested help on how to handle lag between sessions and dose accumulation in mosaiq monitoring.It was ascertained from the logs that a "lame en limite switch" (translated as blade in limit switch) error occurred on the linac which interrupted the treatment delivery.Field 11 received 15.2 mu of the 882.6 mu prescribed at this point.Later that day the remaining 867.4 mu was delivered to field 11.The customer questioned if it was possible to have the partial treatment count as a fraction.Elekta recommend that the customer use the dose and fractions review in mosaiq for options to manage the fraction count.Mosaiq did not have any malfunction and is working as designed and intended.Based on the available information, there was no patient mistreatment.

• 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 SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 21110583
• Report Number: 2950347-2025-00001
• Device Sequence Number: 8682309
• Product Code: IYE
• UDI-Device Identifier: 00858164002336
• UDI-Public: (01)00858164002336(10)2.82.108
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: 12/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2020
• 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