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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

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

Event Date 04/12/2023

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 mosaiq did not record patient prescription.

Manufacturer Narrative

B1 updated h2 updated h6 updated h10 updated the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that they sent a field to the machine for treatment and received an error message.The customer informed that they performed a reset and then were able to treat the patient, however, mosaiq incorrectly recorded the energy for the field.The investigation found from the software logs that the field had been edited and saved with new changes by the user.The user had sent a field for treatment, however treatment was inhibited and an error message was displayed to the user "prescription invalid".The patient had not been treated with this field and the user performed a reset.After the reset, the user entered the field again and this time treatment to the patient was completed.The machine logs show that the field was treated as a static field with 6x energy as prescribed, however mosaiq incorrectly recorded the treatment as an arc with 0 energy.From the treatment/history reports, the same field was treated and recorded correctly with the energy and field type on the other days so this seems to be a one-off recording problem.The customer has been informed to add a logging line item to the vmi section of the impac.Ini file and monitor the daily treatment to see if this same problem occurs again based on the information available there was no patient mistreatment.The issue encountered is a recording problem which would not lead to patient harm.

• 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: 16919022
• MDR Text Key: 315086346
• Report Number: 3015232217-2023-00029
• 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: 08/04/2023

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
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 04/13/2023
• Supplement Dates FDA Received: 08/04/2023
• 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