MAUDE manufacturer profile
PHILIPS NORTH AMERICA LLC · NSA
MAUDE profile for Over-The-Counter Automated External Defibrillator
Key facts
| Manufacturer | PHILIPS NORTH AMERICA LLC |
|---|---|
| Manufacturer group | PHILIPS NORTH AMERICA LLC |
| Product code | NSA |
| Product code name | Over-The-Counter Automated External Defibrillator |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Failure of Device to Self-Test, Failure to Power Up, Inaudible or Unclear Audible Prompt/Feedback, Failure to Run on Battery, Premature Discharge of Battery, Battery Problem, Cardiac Arrest Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1