FDA Adverse Event
Malfunction
Summary report: N
8010042-2008-00029
MDR report key: 1020993
·
Received March 13, 2008
Report
- Report Number
- 8010042-2008-00029
- Event Type
- Malfunction
- Date Received
- March 13, 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 AB. MAQUET CRITICAL CARE AB 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 |