MAUDE Adverse Event Report: BARCO NV BARCO; NEXXISOR, MNA-440 ENC SDI

Model Number NEXXISOR, MNA-440 ENC SDI

Device Problem No Display/Image (1183)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Reported failure: after the introduction of the nis for the interor setup, the black screen issue stabilized for most rooms, except for 2 rooms.+ issue determination difficult: occurrence 1x per month.+ ntp server introduced for better timing determination.+ logfiles provided by support.

• Brand Name: BARCO
• Type of Device: NEXXISOR, MNA-440 ENC SDI
• 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: 18796477
• MDR Text Key: 336516006
• Report Number: 3004455125-2024-00010
• 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
• 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, MNA-440 ENC SDI
• Device Catalogue Number: K9303301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2022
• 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