MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MOSAIQ; MOSAIQ ONCOLOGY INFORMATION SYSTEM

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	01/02/2024
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 that after treatment the recorded beams were not recorded in mosaiq.
Additional Manufacturer Narrative
Section d4 corrected, section h4 updated, section h6 updated, section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.According to machine and audit logs, a field was entered for treatment verification and the machine transitioned to a ready state.The sdd logs were reviewed and confirmed that the prescribed mu was delivered successfully to the field which the customer already manually recorded.There was no patient mistreatment.Mosaiq did not have any malfunction and was working as designed and intended.For an unknown reason, mosaiq never received data from the linac indicating the beam was being delivered.As a result, mosaiq did not record a treatment for the field.Mosaiq is only able to record according to what it receives from the machine.
Additional Manufacturer Narrative
H11: additional information: this is a follow-up to the final report submitted on 07-jun-2024 to notify that due to an administrative error this case was submitted under an incorrect mfr report number (3015232-2024-00007) which captured the wrong manufacturer information.An initial and final (combined) report was submitted under the correct mfr number (see report 2950347-2024-00010) with the correct manufacturer.

• Brand Name: MOSAIQ
• Common Device Name: MOSAIQ ONCOLOGY INFORMATION SYSTEM
• 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: 18629738
• Report Number: 3015232-2024-00007
• Device Sequence Number: 18125354
• 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: 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 06/07/2024; 11/14/2024
• 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