MAUDE manufacturer profile
SORIN GROUP ITALIA SRL. · DTX
MAUDE profile for Gas Control Unit, Cardiopulmonary Bypass
Key facts
| Manufacturer | SORIN GROUP ITALIA SRL. |
|---|---|
| Manufacturer group | SORIN GROUP ITALIA |
| Product code | DTX |
| Product code name | Gas Control Unit, Cardiopulmonary Bypass |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Increase in Pressure, No Clinical Signs, Symptoms or Conditions 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