FDA Adverse Event
Malfunction
Summary report: N
BARCO
MDR report key: 18796478
·
Received February 28, 2024
Report
- Report Number
- 3004455125-2024-00012
- Event Type
- Malfunction
- Date Received
- February 28, 2024
- Date of Event
- June 9, 2023
- Report Date
- February 14, 2024
- Manufacturer
- BARCO NV
- Product Code
- DXJ
- PMA / PMN Number
- K173381
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
BARCO HAS REQUESTED TO RECEIVE MORE INFORMATION FROM THE CUSTOMER, HOWEVER AFTER SEVERAL ATTEMPTS THE CUSTOMER DID NOT PROVIDE ANY FEEDBACK.
Description of Event or Problem · 0
REPORTED FAILURE: DURING AN OPERATION, THE IMAGE FROM THE CONNECTED ENDOSCOPE DISAPPEARED ON ALL 3 DISPLAYS TO WHICH THE SIGNAL WAS ROUTED. WHEN WE CONNECTED TO THE SYSTEM REMOTELY, THE IMAGE WAS THERE AGAIN. WHEN TROUBLESHOOTING, IT TURNED OUT THAT THE CPU UTILIZATION ON THE PC WAS 100% ON ALL 4 CORES. THE OPENJDK PLATFORM BINARY PROCESS WAS CAUSING THE HIGH CPU LOAD. AFTER SHUTTING DOWN AND RESTARTING THE SYSTEM, THE CPU LOAD RETURNED TO NORMAL. TODAY WE RECEIVED ANOTHER TICKET FROM THE OR THAT A DISPLAY DIDN'T SHOW A PICTURE. EVEN NOW THE CPU LOAD WAS AGAIN AT 100%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451313 | BARCO | NEXXISOR, NMS | DXJ | BARCO NV | NEXXISOR NMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |