FDA Adverse Event
Malfunction
Summary report: N
8010042-2008-00009
MDR report key: 1000205
·
Received January 23, 2008
Report
- Report Number
- 8010042-2008-00009
- Event Type
- Malfunction
- Date Received
- January 23, 2008
- Product Code
- CBK
- PMA / PMN Number
- k063404
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET CRITICAL CARE AB 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 |