MAUDE brand profile
SYNCARDIA FREEDOM DRIVER
MAUDE brand safety profile
Key facts
| Brand name | SYNCARDIA FREEDOM DRIVER |
|---|
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Audible Prompt/Feedback Problem, Device Displays Incorrect Message, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, No Patient Involvement, Noise, Audible, Device Operates Differently Than Expected Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1