FDA Adverse Event
Malfunction
Summary report: N
8010042-2008-00014
MDR report key: 1015248
·
Received February 20, 2008
Report
- Report Number
- 8010042-2008-00014
- Event Type
- Malfunction
- Date Received
- February 20, 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 MANUFACTURING FACILITY MAQUET CRITICAL CARE. MAQUET CRITICAL CARE PROVIDES PRODUCT 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 |