MAUDE manufacturer profile
LIVANOVA DEUTSCHLAND · DWC
MAUDE profile for Controller, Temperature, Cardiopulmonary Bypass
Key facts
| Manufacturer | LIVANOVA DEUTSCHLAND |
|---|---|
| Manufacturer group | LIVANOVA DEUTSCHLAND |
| Product code | DWC |
| Product code name | Controller, Temperature, Cardiopulmonary Bypass |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Microbial Contamination of Device, No Clinical Signs, Symptoms or Conditions, No Patient Involvement, No Known Impact Or Consequence To Patient, Bacterial Infection, Temperature Problem, Pumping Problem, No Consequences Or Impact To Patient 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