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

Model Number MOSAIQ

Device Problems Computer Software Problem (1112); Use of Device Problem (1670)

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

Event Date 11/08/2021

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 wrong side of a cbct was treated.

Manufacturer Narrative

Section h6 updated coding.Section h10 additional information.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer imported a plan in which the treatment fields have different isocenter values.Since the isocenter values were not uniform across the plan, mosaiq set the isocenter value in the 'site setup' field to null.For plans in which the treatment fields have different isocenter values, the customer is expected to manually update the isocenter values in the 'site setup' field before treatment.If the isocenter values are not manually entered, the values will remain null, which will cause an application error when the user attempts to perform offline registration in mosaiq.The customer also reported that they could not get the spatial registration object files to be processed by mosaiq.Since the isocenter values were null and were not manually updated by the customer after the plan was imported to mosaiq, mosaiq had an application error, a warning notice was highlighted to the user and mosaiq then processed the spatial registration object files.The audit log shows that the fields were treated and based on the data provided by the customer, the couch positions were within the tolerance set for each field.There were no couch shift offsets applied to the fields, and the patient was treated at the correct positions.There was no patient mistreatment.The root cause was determined to be use error as the customer did not manually update the isocenter values in the site setup field when performing offline registration in mosaiq.Mosaiq did not have any malfunction and was working as designed and intended.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• Manufacturer (Section G): ELEKTA INC; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 13017673
• MDR Text Key: 285496243
• Report Number: 2950347-2021-00024
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: 00858164002282
• 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: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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