FDA Adverse Event
Malfunction
Summary report: N
8010042-2008-00047
MDR report key: 1038288
·
Received April 11, 2008
Report
- Report Number
- 8010042-2008-00047
- Event Type
- Malfunction
- Date Received
- April 11, 2008
- Product Code
- IOY
- 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 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 | IOY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |