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 11/22/2023

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 incorrectly recorded an overdose.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer sent the prescribed fields to the machine for treatment.The treatment was completed as planned but mosaiq gave a fault at the end when receiving records from truebeam and recorded an overdose.From the audit and itcsm logs, fields were sent to the machine for treatment.Mosaiq received dicom treatment beam records whilst it was still receiving the cbct, structure set & sro files.It appears that these beam records were out of sequence which caused the error in the processing of beam segments from these records.This then led to the incorrect recording of monitor units (mus) for two prescribed fields.It has not been possible to establish the root cause.The dicom beam record shows that for one field 506mu was delivered (as prescribed) not 1,031.7mu as recorded and for the other field 594mu was delivered (as prescribed) not 474.3mu as recorded.This was an incorrect recording from mosaiq and there was no patient mistreatment.This recording issue is detectable post treatment and does not affect or lead to patient mistreatment.Mosaiq detects this issue of the monitor units being delivered less than or more than the prescribed mu at the end of the session by displaying a message.If this message is ignored by the user, the next time the patient is treated, the treatment chart will display in 'red' indicating to the user that something mismatched as opposed to displaying black for a completed field.The 'red' will not only display on the session from the previous day but also for the future sessions until the chart is corrected to no longer having more or less monitor units.Mosaiq has multiple ways to mitigate a difference in the monitored units being received versus expected.If the initial message is received, the customer needs to verify the amount delivered via the dicom beam record or ask elekta for assistance.If the dicom beam record does not exist, the customer must request assistance from the linac supplier.

• 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: 18343412
• MDR Text Key: 330778600
• Report Number: 3015232217-2023-00071
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: (01)00858164002367(10)2.84.002
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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