FDA Adverse Event
Malfunction
Summary report: N
8010042-2008-00044
MDR report key: 1028933
·
Received April 4, 2008
Report
- Report Number
- 8010042-2008-00044
- Event Type
- Malfunction
- Date Received
- April 4, 2008
- Product Code
- CBK
- PMA / PMN Number
- K041223
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE PROVIDES PROD FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CBK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |