MAUDE Adverse Event Report: BARCO NV BARCO; NEXXISOR

Model Number MNA-440 ENC / NEXXISOR

Device Problem No Display/Image (1183)

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

Event Date 04/26/2023

Event Type  malfunction  

Event Description

Lost the video routing to 3 monitors at the same time, during a surgery.The patient was not harmed or in danger.

• 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: 18796470
• MDR Text Key: 336421557
• Report Number: 3004455125-2024-00005
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: QA
• PMA/PMN Number: K173381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/26/2024

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 Operator: Health Professional
• Device Model Number: MNA-440 ENC / NEXXISOR
• Device Catalogue Number: K9303300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• 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