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

Device Problem Computer Software Problem (1112)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

The customer reported that a patient was setup incorrectly by using couch move assistant in mosaiq wrong.

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

Manufacturer Narrative

Section g3 date corrected section h6 updated section h11 updated the investigation was completed by conducting a thorough evaluation of the product and the reported information.The investigation found that the couch move assistant (cma) window was manually opened from site setup verification with prescribed offset shifts and the shifts were applied.When the user opened cma from the treatment delivery table, the shifts populated from the linac were the same directional shifts derived from patient's last treatment session.The display of these values in cma cannot be explained or determined and it is believed to be a one-time occurrence.The treatment was not delivered with the table at this position and the entire setup process was repeated.According to the software logs the couch move assistant window was manually opened again with prescribed offset shifts and the shifts were applied and the patient was treated.There is no evidence of mistreatment since the patient was imaged and repositioned after the unexplained values appeared in cma and before treatment was administered.When the cma is opened manually, whether on treatment delivery table or on a treatment field, only one shift can be sent.Once 'send' or 'send/record' is clicked, then both these buttons are disabled so that 'send' cannot repeat.However, once the cma has been closed after performing a shift, there is nothing that prevents the cma from being opened again for another shift to be applied.The issue was not readily reproducible and appears to be a one-time occurrence.

• Brand Name: MOSAIQ
• Type of Device: 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; crawely, west sussex RH10 -9BL
• MDR Report Key: 18380398
• MDR Text Key: 331368781
• Report Number: 3015232217-2023-00074
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.053
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1