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 06/09/2023

Event Type  malfunction  

Manufacturer Narrative

Barco has requested to receive more information from the customer, however after several attempts the customer did not provide any feedback.

Event Description

Reported failure: during an operation, the image from the connected endoscope disappeared on all 3 displays to which the signal was routed.When we connected to the system remotely, the image was there again.When troubleshooting, it turned out that the cpu utilization on the pc was 100% on all 4 cores.The openjdk platform binary process was causing the high cpu load.After shutting down and restarting the system, the cpu load returned to normal.Today we received another ticket from the or that a display didn't show a picture.Even now the cpu load was again at 100%.

• 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: 18796478
• MDR Text Key: 336526290
• Report Number: 3004455125-2024-00012
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2024

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 Model Number: NEXXISOR NMS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2023
• Initial Date FDA Received: 02/28/2024
• 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