FDA Adverse Event
Malfunction
Summary report: N
CNS-9700
MDR report key: 4173618
·
Received September 10, 2014
Report
- Report Number
- 2080783-2014-00048
- Event Type
- Malfunction
- Date Received
- September 10, 2014
- Date of Event
- August 19, 2014
- Report Date
- August 19, 2014
- Manufacturer
- NIHON KOHDEN CORP
- Product Code
- MHX
- 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) LOST ITS VIDEO CONNECTION AFTER A POWER OUTAGE. THE CUSTOMER STATES THAT THE POWER WAS ONLY LOST FOR 5 SECONDS. CNS WAS PLUGGED INTO A UPC AND UPC WAS PLUGGED INTO EMERGENCY POWER. UPC HAS NO FAULTY INDICATOR LIGHTS. MFR REF#: 8030229-2014-00048.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559735 | CNS-9700 | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN CORP | CNS-9700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |