MAUDE Adverse Event Report: BARCO NV BARCO; NEXXISOR, NMS

Model Number NEXXISOR NMS

Device Problem No Display/Image (1183)

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

Event Date 02/22/2023

Event Type  malfunction  

Event Description

Reported failure: there has been an issue in oslo in two interconnected operating rooms.Hybrid or nms 11.12 and hybrid control nms12.12.In both of them the system crashed and no routing was possible during operation.After reboot, one of the devices showed an old preview image, whilst routing the correct video stream.

• Brand Name: BARCO
• Type of Device: NEXXISOR, NMS
• Manufacturer (Section D): BARCO NV; president kennedypark 35; kortrijk, west-vlaanderen 8500 ; BE 8500
• Manufacturer Contact: lieven de wandel ; president kennedypark 35; kortrijk, west-vlaanderen 8500 ; BE 8500
• MDR Report Key: 18796474
• MDR Text Key: 336516057
• Report Number: 3004455125-2024-00011
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K173381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: NEXXISOR NMS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2023
• 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: Unknown
• Patient Sequence Number: 1