FDA Adverse Event
Malfunction
Summary report: N
8010762-2008-00003
MDR report key: 1214880
·
Received September 11, 2008
Report
- Report Number
- 8010762-2008-00003
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Product Code
- KFM
- PMA / PMN Number
- K943803
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE EVENT IS REPORTED TO THE US FDA BECAUSE OF AN MDV REPORT IN ANOTHER COUNTRY, MAQUET INC SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE MAQUET CARDIOPULMONARY. MAQUET CARDIOPULMONARY 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 | KFM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |