MAUDE manufacturer profile
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION · DWA
MAUDE profile for Control, Pump Speed, Cardiopulmonary Bypass
Key facts
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
|---|---|
| Manufacturer group | SAME |
| Product code | DWA |
| Product code name | Control, Pump Speed, Cardiopulmonary Bypass |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Patient Involvement, Device Operates Differently Than Expected, Break, Device Displays Incorrect Message, No Clinical Signs, Symptoms or Conditions, Unable to Obtain Readings, No Display/Image 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