FDA Adverse Event
Other
Summary report: N
9617286-2008-00001
MDR report key: 1051500
·
Received May 16, 2008
Report
- Report Number
- 9617286-2008-00001
- Event Type
- Other
- Date Received
- May 16, 2008
- Product Code
- GWL
- PMA / PMN Number
- K040113
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE SD20 IS COMPRISED OF A HEADBOX UNIT (CAT# D.2120) AND AMPLIFIER UNIT (CAT# D. 2118). THIS IS THEN INTEGRATED WITH OTHER COMPONENTS BY NELLCOR/COVIDIEN TO CREATE A COMPLETE SLEEP DIAGNOSTIC SYSTEM. EB NEURO IS THE MFR OF THE SD20, WHICH IS BELIEVED TO BE THE SOURCE OF THE EVENT. AN INVESTIGATION OF THE DEVICE IS UNDERWAY. WHEN THE INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GWL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |