FDA Adverse Event
Malfunction
Summary report: N
CNS-6201
MDR report key: 4173595
·
Received September 10, 2014
Report
- Report Number
- 8030229-2014-00046
- Event Type
- Malfunction
- Date Received
- September 10, 2014
- Product Code
- MHX
- PMA / PMN Number
- K102376
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEFECTIVE DEVICE REQUESTED FOR FAILURE INVESTIGATION.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559595 | CNS-6201 | CENTRAL MONITOR SYSEM | MHX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |