FDA Adverse Event
Other
Summary report: N
NICOLETONE LTM CENTRAL MONITOR
MDR report key: 2343968
·
Received November 16, 2011
Report
- Report Number
- 3008289288-2011-00008
- Event Type
- Other
- Date Received
- November 16, 2011
- Date of Event
- October 5, 2011
- Report Date
- November 4, 2011
- Manufacturer
- CAREFUSION 209 INC.
- Product Code
- GWQ
- PMA / PMN Number
- K964280
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
NO PT INJURY. EPILEPTIC PT WAS BEING MONITORED FOR EPILEPTIC SEIZURES. THE CENTRAL MONITOR DROPPED OUT, SO WHEN THE PT HAD A SEIZURE AND PUSHED THE PT EVENT BUTTON, THERE WAS NO RESPONSE RECEIVED AT THE NURSES' CENTRAL MONITOR STATION. THE NURSING STAFF HEARD THE PT'S SEIZURE AND WERE ABLE TO ADMINISTER THE APPROPRIATE CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NICOLETONE LTM CENTRAL MONITOR | CENTRAL MONITOR | GWQ | CAREFUSION 209 INC. | 982A0417 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |