MAUDE brand profile
HEARTWARE VENTRICULAR ASSIST SYSTEM CONTROLLER 10
MAUDE brand safety profile
Key facts
| Brand name | HEARTWARE VENTRICULAR ASSIST SYSTEM CONTROLLER 10 |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Power Problem, Loose or Intermittent Connection, Device Displays Incorrect Message, Connection Problem, Protective Measures Problem, Date/Time-Related Software Problem 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