MAUDE Adverse Event Report: ELEKTA INC MOSAIQ; MOSAIQ ONCOLOGY INFORMATION SYSTEM

Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/15/2024
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
Customer reported a concern that the dose may not have been calculated correctly.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the products and the reported information.The customer reported that patients were treated at fully extended table and that there was concern that the dose may not have been calculated correctly with pinacle.In this scenario, the treatment table that the patient lies on was fully extended so that the high-density (metal) parts of the table were in the beam path.When a patient is treated with the treatment table in this position, the dose attenuation would result in an underdose that is possible to compensate for (non-serious).Mosaiq did not have any malfunction and was found to be working as designed and intended.An investigation was also performed on the versa hd linac.Elekta performed a risk assessment and assessed the severity to be "non-serious" and probability to be "implausible" if this were to re-occur.The risk assessment concluded that the risk is considered low (see mfr no 9617016-2024-00005, elekta ref.#(b)(4)).

• Brand Name: MOSAIQ
• Common Device Name: MOSAIQ ONCOLOGY INFORMATION SYSTEM
• 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: 20265170
• Report Number: 2950347-2024-00005
• Device Sequence Number: 8298720
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.294
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 08/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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