FDA Adverse Event
Malfunction
Summary report: N
ROTAFLOW CENTRIFUGAL PUMP
MDR report key: 782766
·
Received November 9, 2006
Report
- Report Number
- 8010042-2006-00107
- Event Type
- Malfunction
- Date Received
- November 9, 2006
- Report Date
- October 25, 2006
- Manufacturer
- MAQUET CRITICAL CARE AB
- Product Code
- DWA
- PMA / PMN Number
- K061072
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
MAQUET CRITICAL CARE AB HAS NOT RECEIVED THE ROTAFLOW FROM CUSTOMER YET. MAQUET, INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE, AB, SOLNA SWEDEN. MAQUET CRITICAL CARE AB PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.
Description of Event or Problem · 1
THE ROTAFLOW STOPPED AND GAVE ERROR "RUNAWAY".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ROTAFLOW CENTRIFUGAL PUMP | KFM | DWA | MAQUET CRITICAL CARE AB | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |