MAUDE Adverse Event Report: BARCO NV BARCO; NEXXISOR, MNA-240

Model Number MNA-240 ENC DP KS

Device Problem No Display/Image (1183)

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

Event Date 02/22/2022

Event Type  malfunction  

Manufacturer Narrative

A medical specialist has confirmed that the extension of anesthesia, as reported by the customer, did not pose an additional risk to the patient.

Event Description

The customer has informed barco that they received the following information from the hospital: all monitors are black when booting up in the morning.System up and down several times.Time delay approx.20 minutes until the decoder on the equipment trolley worked and sent a signal.Everything was stable for the rest of the day.The next morning there were no problems at starting.It was a user error that the emergency line was on the wrong video input /4k instead of 1080p.It is not clear who set this.The patient received extended anesthesia.The surgery could not be started.

• Brand Name: BARCO
• Type of Device: NEXXISOR, MNA-240
• 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: 18796484
• MDR Text Key: 336417993
• Report Number: 3004455125-2024-00007
• 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: Recall
• 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-240 ENC DP KS
• Device Catalogue Number: K9303098A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2022
• 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
• Removal/Correction Number: RECALL NUMBER Z-1854-202
• Patient Sequence Number: 1