MAUDE manufacturer profile
PHILIPS MEDICAL SYSTEMS · MKJ
MAUDE profile for Automated External Defibrillators (Non-Wearable)
Key facts
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
|---|---|
| Manufacturer group | PHILIPS MEDICAL SYSTEMS |
| 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
- 100–999 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Patient Involvement, Device Operates Differently Than Expected, Failure of Device to Self-Test, Device Displays Incorrect Message, No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Failure to Power Up 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