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

Model Number MOSAIQ

Device Problems Computer Software Problem (1112); Compatibility Problem (2960)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2020

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 a cbct registration sent to mosaiq resulted in larger shifts than actually transpired at truebeam.The customer has attempted to reconstruct and re-register but is unable to reproduce.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer (dr.(b)(6) ) was using truebeam which is a third-party device.The third-party supplier (varian) informed elekta of the issue.The user had noticed that the table positions for the cbct field did not match the couch positions of the treatment field.Based on mosaiq functionality, the couch position values for the cbct will record back in mosaiq the image acquisition position.The truebeam (varian) linac does not have the capability to return a beam record for cbct images to mosaiq.If the cbct image were returned to mosaiq then it would display the beam record from the data inside the cbct image and that data would be the acquisition couch position.Acquisition couch position is encoded in the cbct and the image registration results are encoded independent of couch position.These functionalities within mosaiq are available to this user however truebeam cannot transfer the cbct image as preferred in this scenario.Mosaiq did not have any malfunction and was working as designed and intended.There was no patient mistreatment.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale CA 94086
• MDR Report Key: 10465397
• MDR Text Key: 204715049
• Report Number: 2950347-2020-00030
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: 00858164002091
• Combination Product (y/n): N
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1