FDA Adverse Event
Malfunction
Summary report: N
8010042-2008-00010
MDR report key: 1000229
·
Received January 25, 2008
Report
- Report Number
- 8010042-2008-00010
- Event Type
- Malfunction
- Date Received
- January 25, 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 CRICTICAL 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 |