FDA Adverse Event
Malfunction
Summary report: N
BARCO
MDR report key: 18807890
·
Received February 29, 2024
Report
- Report Number
- 3004455125-2024-00013
- Event Type
- Malfunction
- Date Received
- February 29, 2024
- Date of Event
- February 6, 2024
- Report Date
- February 29, 2024
- Manufacturer
- BARCO NV
- Product Code
- KQM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
WE WERE INFORMED ABOUT AN EVENT WHERE A BARCO MONITOR CHANGED COLOUR AND SHOWED INTERFERENCE ON THE SCREEN DURING A TURP PROCEDURE USING DIATHERMY. THIS WAS EXPERIENCED BY A SURGEON AT A CRITICAL TIME IN THE PROCEDURE. THE PROCEDURE WAS PROCEEDED BY USING ANOTHER MONITOR. THERE WAS NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 898436 | BARCO | MDSC-8231 | KQM | BARCO NV | MDSC-8231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |