MAUDE manufacturer profile
LIVANOVA DEUTSCHLAND · KRL
MAUDE profile for Detector, Bubble, Cardiopulmonary Bypass
Key facts
| Manufacturer | LIVANOVA DEUTSCHLAND |
|---|---|
| Manufacturer group | LIVANOVA DEUTSCHLAND |
| Product code | KRL |
| Product code name | Detector, Bubble, Cardiopulmonary Bypass |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Low Readings, Device Sensing Problem, No Consequences Or Impact To Patient, Over-Sensing, False Alarm, Under-Sensing, Deflation 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