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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2023

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 kv portal images were taken but did not show in the treatment chart.

Manufacturer Narrative

H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported kv portal images were taken but did not show in the treatment chart.The imageacquisitiondatamsg log and audit log confirm that kv (kilovoltage) fields were sent to xvi to be imaged in kv mode.After the images were taken however, the acquisitioncompletedatamsg log shows that null (blank) was returned as the acquisition mode from xvi although kv acquisition mode had been sent by mosaiq prior to imaging.Due to this acquisition mode discrepancy, mosaiq will not record the field in the treatment chart.This issue is limited to recording the images in the treatment chart and did not affect clinical patient setup.In-house testing has shown that when xvi returns a blank acquisitionmode in the acquisition complete message, it means the user has dropped out of the fully online synergistiq mode and manually selected the preset on xvi.Mosaiq did not have any malfunction and is working as designed and intended.Based on the available information, 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
• Manufacturer (Section G): ELEKTA INC; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 17238614
• MDR Text Key: 318322864
• Report Number: 2950347-2023-00003
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: (01)00858164002091(10)2.64.296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/30/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 10/09/2023
• 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