MAUDE manufacturer profile
SYNCARDIA SYSTEMS, LLC · LOZ
MAUDE profile for Artificial Heart
Key facts
| Manufacturer | SYNCARDIA SYSTEMS, LLC |
|---|---|
| Manufacturer group | SYNCARDIA SYSTEMS, LLC |
| Product code | LOZ |
| Product code name | Artificial Heart |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Device Displays Incorrect Message, Audible Prompt/Feedback Problem, No Patient Involvement, Adverse Event Without Identified Device or Use Problem, Battery 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