MAUDE brand profile
HEARTWARE VENTRICULAR ASSIST SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | HEARTWARE VENTRICULAR ASSIST SYSTEM |
|---|
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 100–999 Problems flagged by Orca1 signal analytics
- No Consequences Or Impact To Patient, Adverse Event Without Identified Device or Use Problem, Battery Problem, Connection Problem, No Known Impact Or Consequence To Patient, Loose or Intermittent Connection, Power Problem, Death 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