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

Model Number MOSAIQ

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896)

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

Event Date 09/14/2020

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 mosaiq disconnected on the sequencer.

Manufacturer Narrative

Description updated information added coding updated the investigation was completed by conducting a thorough evaluation of the product and the reported information.Based on the analysis of the software logs, the error messages seen by the user were displayed when one of the three fields was selected for treatment.It is possible that there were network communication issues at the time the field was selected because the time expired whilst waiting on a response from the treatment machine, hence the messages were displayed.Mosaiq correctly recorded the dose and presented this to the user.Mosaiq did not have any malfunction and was working as designed and intended.There was no mistreatments to the patients.

Event Description

The customer reported mosaiq disconnected from the sequencer with a couple errors when treating multiple patients.

• 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: 10689746
• MDR Text Key: 211686651
• Report Number: 2950347-2020-00034
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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: 09/17/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1