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

Model Number MOSAIQ

Device Problems Computer Software Problem (1112); Device Handling Problem (3265)

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

Event Date 10/30/2021

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 beam interrupt issue with mosaiq.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer was performing linac beam delivery tests after a mosaiq upgrade.After the treatment beam was started, the customer interrupted the beam and moved a geometric position.Once beam on is initiated, mosaiq can no longer verify geometrical positions as mosaiq would not be able to keep up with the change in positions of the gantry or mlc leaves.If mosaiq tried to verify, it would result in continuous stoppage of delivery.When the beam is interrupted whilst it is on, the interface does not provide communication between the machine and mosaiq and an inhibit is not raised.Mosaiq did not have any malfunction and was working as designed and intended.The root cause was determined to be use error since there was an unintentional movement after completing the setup correctly and the device had been beamed on.No patients were involved during the test that the customer performed.

• 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: 12922922
• MDR Text Key: 281658738
• Report Number: 2950347-2021-00023
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002367
• UDI-Public: 00858164002367
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• 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: 11/05/2021
• 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