FDA Adverse Event
Malfunction
Summary report: N
BARCO
MDR report key: 18796485
·
Received February 28, 2024
Report
- Report Number
- 3004455125-2023-00004
- Event Type
- Malfunction
- Date Received
- February 28, 2024
- Date of Event
- November 23, 2022
- Report Date
- February 26, 2024
- Manufacturer
- BARCO NV
- Product Code
- DXJ
- PMA / PMN Number
- K173381
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
MONITOR 1 IMAGE DROPPED TWICE AROUND 10:00 AND 11:00 AM THE CABLES HAVE BEEN CHECKED AND MOVED, BUT EVERYTHING WAS FINE AND NOTHING FELL OUT VIDEO STREAM GONE BECAUSE OF REBOOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 452351 | BARCO | NEXXISOR | DXJ | BARCO NV | NEXXISOR / MDSC-8232 M3D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |