MAUDE brand profile
HEARTSTART MRX
MAUDE brand safety profile
Key facts
| Brand name | HEARTSTART MRX |
|---|
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, No Known Impact Or Consequence To Patient, Device Operates Differently Than Expected, Device Displays Incorrect Message, No Clinical Signs, Symptoms or Conditions, Battery Problem, Break, Failure of Device to Self-Test 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