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 06/27/2023

Event Type  malfunction  

Event Description

The customer reported an id mismatch issue.

Manufacturer Narrative

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

Manufacturer Narrative

Section b1 updated.Section b3 date corrected.Section g2 clm number corrected.This mfr report 3015232217-2023-00046 is related to clm 03423857, not clm 03412863 as incorrectly shown in the initial report.Section h6 updated coding.Section h11 updated.The investigation was completed by conducting a thorough evaluation of the product and the related information.The customer selected a patient for treatment, but the global patient's name and id did not update in the upper right corner of the screen after being selected in mosaiq.The previous patient continued to be displayed in the global patient's name and id.The customer provided a screenshot showing the discrepancy.According to the logs, fields 1.1 and 1.2 were fully treated/recorded as prescribed.There was no patient mistreatment.The issue was determined to be a defect within mosaiq, however the defect was determined not to be a risk.The defect occurs when the user opens the patient chart from a scheduling window which helps the user to select the intended chart.The user will need to left click on the mouse to highlight the correct appointment and then right click the mouse to open the correct patient chart.If this action is done too fast by the user, the new chart might not open as expected because the application has not finished processing the highlighted appointment before it starts to process the "open chart" process.The root cause would be a potential delay in the left mouse click process finishing before the right mouse click picks up the actual highlighted appointment.Opening a chart from a scheduling window is not confirmation that the correct patient chart is being used.The passive and configurable displays in mosaiq can be used to verify patient's identity: 1.Passive.The patient's name and patient id are displayed at the top of the treatment chart and on every screen throughout mosaiq.2.Configurable.A photo of the patient can be displayed whenever the patient's chart is opened as well as in site setup verification on the "setup" tab in the photo/diagram section.Patient verification for conventional radiation treatment can be implemented.Patient verification can be implemented using external systems via a patient verification interface e.G.Fingerprint and facial recognition.In addition, there are routine checks done by the therapist in the clinic to verify the patient's identity (other than using barcodes).1.Asking the patient their name.2.Asking the patient their date of birth.3.Asking the patient what procedure they are scheduled for.4.Verifying that all the patient information provided by the patient matches the information displayed in the mosaiq screen displays and treatment schedule.The display of the wrong patient chart would not result in patient harm and is not a safety issue.

• 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: 17508157
• MDR Text Key: 320878424
• Report Number: 3015232217-2023-00046
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.83.040
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2021
• 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