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

Model Number	MOSAIQ
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an issue when exceeding table target calculated from cbct.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was found to be a defect in the product.The customer reported an issue when exceeding table target calculated from cbct.The customer used a random patient to capture data to explain the problem so there was no mistreatment.When the couch move assist (cma) feature is used with the pps interface enabled in the mac, the couch angles are first achieved.When the couch is moved out of position, a message "couch targets not achieved" should be displayed and blue indicators should be displayed next to the couch values that are out of tolerance.The investigation found that this does not happen.The message still displays "couch targets achieved" and no blue indicators are displayed.If the user fails to notice that the couch is in the wrong place and proceeds with the treatment, the wrong area of the patient could be treated resulting in a geometric miss.When exiting cma, there will be a warning that "couch targets not achieved", so the error should be caught after one fraction.However, if treatments are hypofractionated, deviations of 1.5 - 2.5 mm from the intended target could go undetected.Elekta performed a risk assessment and assessed the severity as "non-serious" " and probability "incredible which is within the acceptable region.The customer has been informed that the issue has been fixed in mosaiq version 2.83 and higher.

• 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: 17324122
• Report Number: 3015232217-2023-00041
• Device Sequence Number: 20412882
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2023

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 Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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