MAUDE manufacturer profile
SORIN GROUP DEUTSCHLAND GMBH · DWC
MAUDE profile for Controller, Temperature, Cardiopulmonary Bypass
Key facts
| Manufacturer | SORIN GROUP DEUTSCHLAND GMBH |
|---|---|
| Manufacturer group | SORIN GROUP DEUTSCHLAND |
| Product code | DWC |
| Product code name | Controller, Temperature, Cardiopulmonary Bypass |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Microbial Contamination of Device, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, No Patient Involvement, Bacterial Infection, Adverse Event Without Identified Device or Use Problem, Device Displays Incorrect Message, Other (for use when an appropriate device code cannot be identified) Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1