MAUDE brand profile
HEARTSTART XLDEFIBRILLATORMONITOR
MAUDE brand safety profile
Key facts
| Brand name | HEARTSTART XLDEFIBRILLATORMONITOR |
|---|
At a glance
- 100–999 MAUDE reports
- 100–999 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Failure of Device to Self-Test, Battery Problem, Failure to Power Up, Incorrect, Inadequate or Imprecise Result or Readings, Failure to Deliver Shock/Stimulation, Electrical /Electronic Property Problem, No Patient Involvement 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