MAUDE Adverse Event Report: BARCO NV BARCO; NEXXISOR

Model Number MNA-140 PCIE KS

Device Problem No Display/Image (1183)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

Barco has concluded that the loss of video signal is caused by a problem with the sfp modules, which is related to maintenance.After replacement of the sfp modules the problem was solved.We have no feedback since then despite several attempts.

Event Description

The customer has informed barco that they received the following information from the hospital: image loss intraoperatively.There will now be a swissmedic message from the customer.Intraoperative image failure of the two monitors (dec dp4k) in the sterile field and the 55" barco with built-in dec on the wall.Only the secureline would have worked (12g-sdi) but was switched incorrectly.Now the customer has again received the setting for switching the secureline via video.I played it through with him via video support.It works perfectly.As far as i know, no patient was harmed.

• Brand Name: BARCO
• Type of Device: NEXXISOR
• 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: 18796471
• MDR Text Key: 336515983
• Report Number: 3004455125-2024-00009
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: Repair
• 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: MNA-140 PCIE KS
• Device Catalogue Number: K9303123A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: No
• 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