MAUDE brand profile
HEARTMATE 3 SYSTEM CONTROLLER US
MAUDE brand safety profile
Key facts
| Brand name | HEARTMATE 3 SYSTEM CONTROLLER US |
|---|
At a glance
- 10–99 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 Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Communication or Transmission Problem, Electrical Power Problem, Mechanical Problem, Connection Problem, Infusion or Flow Problem, Failure to Charge 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