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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the mosaiq barcode selected an incorrect patient.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that the mosaiq barcode selected an incorrect patient.The cause was traced to a defect in the software coding which would not result in patient harm.The barcode defect occurs when opening the patient chart which is many steps removed from the treatment delivery.While opening a chart from a scheduling window might be convenient, it is not confirmation that the correct patient chart is being used.There is passive as well as configurable displays in mosaiq that can be used to verify patient identity.For example: passive: the patient's name and patient id are displayed at the top of the treatment chart and on every screen throughout mosaiq.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 (always required for particle therapy).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 identity (other than using barcodes).Asking the patient their name; asking the patient their date of birth; asking the patient what procedure they are scheduled for; verifying that all the patient information provided by the patient matches the information displayed in the mosaiq screen displays and treatment schedule.Therefore, an incorrect barcode scan from the location schedule on its own would not result in patient harm.Based on the available information there has been no mistreatment.The software defect has been fixed in mosaiq 2.83 sp2, mosaiq 3.10 sp1 & mosaiq 3.1.1.0 with the following change: change code to synchronize patient parse from barcode and patient switch, to avoid patient change by the other thread in the middle of the two steps.

• 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; crawley, west sussex RH10 -9BL
• MDR Report Key: 17002636
• MDR Text Key: 315932928
• Report Number: 3015232217-2023-00034
• 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: CH
• 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: 07/07/2023

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
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• 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