MAUDE manufacturer profile
THORATEC SWITZERLAND GMBH · QNR
MAUDE profile for Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Key facts
| Manufacturer | THORATEC SWITZERLAND GMBH |
|---|---|
| Manufacturer group | THORATEC SWITZERLAND GMBH |
| Product code | QNR |
| Product code name | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Device Difficult to Setup or Prepare, Noise, Audible, Unexpected Shutdown, Mechanical Problem, Infusion or Flow Problem 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