FDA Adverse Event
Malfunction
Summary report: N
BARCO
MDR report key: 18796475
·
Received February 28, 2024
Report
- Report Number
- 3004455125-2024-00008
- Event Type
- Malfunction
- Date Received
- February 28, 2024
- Date of Event
- March 9, 2022
- Report Date
- February 14, 2024
- Manufacturer
- BARCO NV
- Product Code
- DXJ
- PMA / PMN Number
- K173381
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
REPORTED FAILURE: PROBLEM IN OSLO INTERVENTION OR7 - HYBRID OR. ALL SOURCES HAD DISAPPEARED FROM THE SCREEN. WE DID A REMOTE LOGIN AND COULD NOT REACH NMS. PC AND NMS SERVICE RESTARTED A FEW TIMES, NO LUCK. ALL OTHER VLANS ON THE SWITCH UNAFFECTED AND ALL OTHER NMS FULLY FUNCTIONAL. NMS UNINSTALLED, RENAMED THE PROGRAMME DATA AND DELETED THE PROGRAMME FILES AND THEN A NEW INSTALL OF NMS. AFTER RE-INSTALL, RECONFIGURATION OF NMS AND RE-LICENSING NMS WAS WORKING AGAIN. THIS WAS VERY UNFORTUNATE AS THE PATIENT WAS ALREADY ON THE TABLE AND READY TO START THE OPERATION THIS MORNING. THE OPERATION HAD TO BE DELAYED BY 35 MINUTES UNTIL I HAD THE SYSTEM REPAIRED. LUCKILY WE GOT IT BACK WORKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 451310 | BARCO | NEXXISOR, NMS | DXJ | BARCO NV | NEXXISOR NMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |