FDA Adverse Event
Malfunction
Summary report: N
CNS-9700
MDR report key: 4173615
·
Received September 10, 2014
Report
- Report Number
- 2080783-2014-00045
- Event Type
- Malfunction
- Date Received
- September 10, 2014
- Date of Event
- August 14, 2014
- Report Date
- August 14, 2014
- Manufacturer
- NIHON KOHDEN CORP
- Product Code
- MHX
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE CENTRAL MONITORING SYSTEM (CNS) SCREEN WENT BLANK A FEW TIMES, EACH TIME THE CUSTOMER POWERED THE SCREEN ON THEN OFF. IT CAME BACK ON BUT WOULD GO DARK AGAIN. MFR REF #:8030229-2014-00045.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559590 | CNS-9700 | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN CORP | CNS-9700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |