MAUDE brand profile
HEARTSTREAM FR2
MAUDE brand safety profile
Key facts
| Brand name | HEARTSTREAM FR2 |
|---|
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Failure of Device to Self-Test, No Consequences Or Impact To Patient, Failure to Power Up, Device Displays Incorrect Message, Death, Premature Discharge of Battery 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