FDA Adverse Event Malfunction Summary report: N

BARCO

MDR report key: 23509387 · Received November 10, 2025

Report

Report Number: 3004455125-2025-00003
Event Type: Malfunction
Date Received: November 10, 2025
Date of Event: October 21, 2025
Report Date: December 4, 2025
Manufacturer: BARCO NV
Product Code: KQM
UDI-DI: 05415334001817
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THERE HAVE BEEN SIMILAR COMPLAINTS IN WHICH WE NOTICED THAT THE CUSTOMER HAD NOT CONNECTED THE POTENTIAL EQUALIZATION (POAG) CONNECTOR. IN THIS ISSUE OUR SERVICE ENGINEERS HAVE DETECTED THAT THE POAG WAS CONNECTED, BUT NOT IN THE CORRECT WAY. WE BELIEVE THAT THIS HAS CAUSED THE SIGNAL LOSS.

Additional Manufacturer Narrative · 0

IT HAS BEEN CONFIRMED THAT THE POAG WAS NOT CONNECTED, DESPITE BARCO'S INSTRUCTION TO DO SO. WE HAVE REACHED OUT TO THE CUSTOMER AND HAVE BEEN PROVIDED WITH SOME ADDITIONAL INFORMATION: - THIS WAS ONLY HAPPENING AT THIS ONE HOSPITAL IN ONE PARTICULAR THEATRE, THAT IS BEING USED WITH DIATHERMY TOOLS. - IT HAPPENS ON ANY REPLACEMENT MDSC-8231 MNA MONITOR THAT IS IN THIS THEATRE. - IT ALWAYS HAPPENS AT THE END OF THE DAY, BETWEEN 4PM AND 5PM. - CURRENTLY THEY HAVE REMOVED THESE MONITORS FROM THIS ROOM AND ARE USING THE OLYMPUS MONITORS ON THE DIATHERMY STACK FOR THESE PROCEDURES. THE AFFECTED DEVICE WAS NOT RETURNED TO BARCO.

Description of Event or Problem · 0

THE DISPLAY WENT BLANK TWICE DURING A TURP PROCEDURE. THE STAFF WAS UNABLE TO REBOOT IT. THERE WAS ANOTHER SCREEN AVAILABLE ON A DIFFERENT STACK. THE PROCEDURE WAS EXTENDED BECAUSE OF THE ISSUE AND WAS COMPLETED USING THE SCREEN ON THE OTHER STACK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2524421	BARCO	SURGICAL DISPLAY	KQM	BARCO NV	MDSC-8231		05415334001817

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown