MAUDE brand profile
HEARTSTART XL DEFIBRILLATORMONITOR
MAUDE brand safety profile
Key facts
| Brand name | HEARTSTART XL DEFIBRILLATORMONITOR |
|---|
At a glance
- 1,000+ MAUDE reports
- 10–99 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 Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Failure of Device to Self-Test, Device Operates Differently Than Expected, Device Displays Incorrect Message, Failure to Power Up, Battery 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