FDA Adverse Event
Malfunction
Summary report: N
CNS-6201
MDR report key: 3952042
·
Received June 18, 2014
Report
- Report Number
- 2080783-2014-00011
- Event Type
- Malfunction
- Date Received
- June 18, 2014
- Date of Event
- May 27, 2014
- Report Date
- May 27, 2014
- Manufacturer
- NIHON KOHDEN CORPORATION
- Product Code
- MSX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE CENTRAL MONITORING SYSTEM (CNS) SCREENS WENT BLACK AND SHOWED AN ERROR MESSAGE "THE PROBLEM HAS BEEN DETECTED AND WINDOWS HAS BEEN SHUT DOWN TO PREVENT DAMAGE TO YOUR COMPUTER. PROBLEM CAUSED BY A FILE NV4/DISP". REF # MFR 8030229-2014-00011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359188 | CNS-6201 | CENTRAL MONITOR SYSTEM | MSX | NIHON KOHDEN CORPORATION | CNS-6201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |