FDA Adverse Event
Malfunction
Summary report: N
CNS-6201
MDR report key: 4949369
·
Received July 27, 2015
Report
- Report Number
- 2080783-2015-00184
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Date of Event
- June 30, 2015
- Report Date
- June 30, 2015
- Manufacturer
- NIHON KOHDEN CORP.
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- WA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CUSTOMER STATED THAT THE CENTRAL MONITORING SYSTEM (CNS) WAS FROZEN IN THE NIHON KOHDEN SPLASH SCREEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 485741 | CNS-6201 | MHX | NIHON KOHDEN CORP. | CNS-6201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |