FDA Adverse Event
Summary report: N
CNS-6201
MDR report key: 3952040
·
Received June 18, 2014
Report
- Report Number
- 2080783-2014-00009
- Date Received
- June 18, 2014
- Date of Event
- May 22, 2014
- Report Date
- May 22, 2014
- Manufacturer
- NIHON KOHDEN AMERICA, INC.
- Product Code
- MHX
- PMA / PMN Number
- K102376
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
ERROR MESSAGE INDICATIVE OF A HARD DRIVE (HDD) FAILURE. HDD TO BE REPLACED IN UNIT.
Description of Event or Problem · 1
THE CENTRAL MONITORING SYSTEM (CNS) SCREEN FROZE UP AND UPON THE REBOOT OF THE CNS, THE SYSTEM IS STUCK AT THE CNS BOOT SCREEN AND THE APPLICATION WILL NOT START CORRECTLY. THERE IS AN RAID ERROR MESSAGE ON THE SCREEN ALSO. THIS UNIT IS NOT IN PRODUCTION AND IS NOT MONITORING PATIENTS AT THIS TIME. REF #MFR 8030229-2014-00009.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358735 | CNS-6201 | CENTRAL MONITOR SYSTEM | MHX | NIHON KOHDEN AMERICA, INC. | CNS-6201 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |