MAUDE manufacturer profile
PHILIPS NORTH AMERICA LLC · MKJ
MAUDE profile for Automated External Defibrillators (Non-Wearable)
Key facts
| Manufacturer | PHILIPS NORTH AMERICA LLC |
|---|---|
| Manufacturer group | PHILIPS NORTH AMERICA LLC |
| Product code | MKJ |
| Product code name | Automated External Defibrillators (Non-Wearable) |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Failure of Device to Self-Test, Battery Problem, Electrical /Electronic Property Problem, Failure to Power Up, Defibrillation/Stimulation Problem, Unable to Obtain Readings, Power Problem 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