FDA Adverse Event
Injury
Summary report: N
MAQUET CARDIOPULMONARY AG
MDR report key: 3652971
·
Received February 6, 2014
Report
- Report Number
- 8010762-2014-00040
- Event Type
- Injury
- Date Received
- February 6, 2014
- Manufacturer
- MAQUET CARDIOPULMONARY AG
- Product Code
- KFM
- PMA / PMN Number
- K991864
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY AG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 76924 | MAQUET CARDIOPULMONARY AG | ROTAFLOW CONSOLE | KFM | MAQUET CARDIOPULMONARY AG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |