MAUDE manufacturer profile
GENTHERM MEDICAL, LLC · DWC
MAUDE profile for Controller, Temperature, Cardiopulmonary Bypass
Key facts
| Manufacturer | GENTHERM MEDICAL, LLC |
|---|---|
| Manufacturer group | GENTHERM MEDICAL, LLC |
| Product code | DWC |
| Product code name | Controller, Temperature, Cardiopulmonary Bypass |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Insufficient Heating, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Insufficient Information, Temperature Problem, Smoking, Insufficient Cooling 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