MAUDE manufacturer profile
PERFUSION SYSTEMS · DWE
MAUDE profile for Tubing, Pump, Cardiopulmonary Bypass
Key facts
| Manufacturer | PERFUSION SYSTEMS |
|---|---|
| Manufacturer group | PERFUSION SYSTEMS |
| Product code | DWE |
| Product code name | Tubing, Pump, 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
- No Clinical Signs, Symptoms or Conditions, Obstruction of Flow, Noise, Audible, Fluid/Blood Leak, Crack, No Consequences Or Impact To Patient, Material Puncture/Hole, No Known Impact Or Consequence 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