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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

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 for a patient receiving a treatment fraction one of the fields was treated, but not recorded in mosaiq.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.From the machine logs it has been determined that mosaiq was in the process of recording the beam records when mosaiq was re-started.After mosaiq re-started, the beam records for these fields were lost and the site manually recorded.When this issue occurs, it is obvious to the user that the treatment was not recorded (or recorded incorrectly).With the data from the machine log, the user (with help from our product support) would be able to verify the actual treatment and the user could record manually what was treated or correct any incomplete/incorrect treatment.This issue would not lead to serious injury.

• Brand Name: MOSAIQ
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): ELEKTA INC; 100 mathilda place; 5th floor; sunnyvale, ca
• MDR Report Key: 9799552
• MDR Text Key: 188494238
• Report Number: 2950347-2020-00008
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

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
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/06/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 06/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1