MAUDE Adverse Event Report: BARCO NV BARCO; NEXXISOR

Model Number NEXXISOR / MNA-440 ENC

Device Problem No Display/Image (1183)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

Fault: image drop out during surgery x2 image routed to 2 displays and both the video went down : life line connected to dislay with the mna-240 took over.1: patient was not injured.2: lifeline was activated, and after a while automatically switched back down nexxis.

• Brand Name: BARCO
• Type of Device: NEXXISOR
• Manufacturer (Section D): BARCO NV; president kennedypark 35; kortrijk, 8500 ; BE 8500
• Manufacturer (Section G): BARCO NV; president kennedypark 35; kortrijk, 8500 ; BE 8500
• Manufacturer Contact: lieven de wandel ; president kennedypark 35; kortrijk, 8500 ; BE 8500
• MDR Report Key: 18796469
• MDR Text Key: 336516044
• Report Number: 3004455125-2024-00006
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K173381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NEXXISOR / MNA-440 ENC
• Device Catalogue Number: K9303300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1