MAUDE manufacturer profile
SORIN GROUP DEUTSCHLAND · DTX
MAUDE profile for Gas Control Unit, Cardiopulmonary Bypass
Key facts
| Manufacturer | SORIN GROUP DEUTSCHLAND |
|---|---|
| Manufacturer group | SORIN GROUP DEUTSCHLAND |
| Product code | DTX |
| Product code name | Gas Control Unit, Cardiopulmonary Bypass |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Device Displays Incorrect Message, No Patient Involvement, Device Operates Differently Than Expected, Other (for use when an appropriate device code cannot be identified), No Patient involvement, Insufficient Flow or Under Infusion, Improper Flow or Infusion 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