MAUDE manufacturer profile
LIVANOVA USA INC. · DWC
MAUDE profile for Controller, Temperature, Cardiopulmonary Bypass
Key facts
| Manufacturer | LIVANOVA USA INC. |
|---|---|
| Manufacturer group | LIVANOVA DEUTSCHLAND |
| Product code | DWC |
| Product code name | Controller, Temperature, Cardiopulmonary Bypass |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Microbial Contamination of Device, Unspecified Infection, Bacterial Infection, Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Death, No Known Impact Or Consequence To Patient, Fatigue 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