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

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 a patient was set up on the ct in 2 different positions: head first supine to treat shoulder; feet first supine to treat femur.Patient details were sent from prosoma (a third party treatment planning system) to mosaiq and patient position was displayed correctly on prosoma documentation.The customer experienced patient orientation being incorrectly displayed in site set up and site set up being correct but editable when it should be locked.Based on the available information, there have been no actual mistreatment.

Manufacturer Narrative

The investigation was completed by conducting a thorough evaluation of the product and the reported information.Mosaiq is working as designed and intended.The customer has already made the necessary workflow adjustments based on the software functionality.Based on the available information, there was no mistreatment in this case.

• 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 ; linac house; fleming way; crawley, west sussex RH10 -9RR ; UK RH10 9RR
• MDR Report Key: 7132916
• MDR Text Key: 95470400
• Report Number: 2950347-2017-00033
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002091
• UDI-Public: 00858164002091
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K141572
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• 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