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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

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

Event Date 05/22/2020

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 that the anatomical shifts from a previous scan were saved in mosaiq 3d image when no shifts were applied, this is now an incorrect record of what has occurred.

Manufacturer Narrative

The investigation ascertained that xvi sends the online setup correction directly to the couch as expected and therefore the patient is treated correctly.The customer completed two cone beam ct (cbcts).The first cbct (cbct1) had a shift that was used for treatment and a record was made in mosaiq - tpo (third-party offset) - tpo1.The couch was shifted and a second cbct (cbct2) was taken.As the patient was in the correct position, there was no tpo corresponding to the second cbct.After treatment, in 3d image registration, third party offsets must be associated with a cbct for review.A tpo is automatically associated if it is the only tpo recorded within a limited time period close to the time of the cbct.In this case, the cbct not requiring correction was opened, the tpo from the first cbct was automatically associated.This incorrect offset will result in a registration that is not acceptable.This incorrect association may be identified and the review aborted or the fusion result will be rejected.This issue would not result in patient harm and is not a safety issue.

• 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: 10167095
• MDR Text Key: 195556539
• Report Number: 2950347-2020-00019
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: 00858164002282
• Combination Product (y/n): N
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1