MAUDE brand profile
HEARTMATE II SYSTEM CONTROLLER US EP
MAUDE brand safety profile
Key facts
| Brand name | HEARTMATE II SYSTEM CONTROLLER US EP |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Mechanical Problem, Electrical Power Problem, Complete Loss of Power, Disconnection, No Apparent Adverse Event, Insufficient Information 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