MAUDE manufacturer profile
PHYSIO-CONTROL, INC · MKJ
MAUDE profile for Automated External Defibrillators (Non-Wearable)
Key facts
| Manufacturer | PHYSIO-CONTROL, INC |
|---|---|
| Manufacturer group | PHYSIO-CONTROL, INC. - 3015876 |
| Product code | MKJ |
| Product code name | Automated External Defibrillators (Non-Wearable) |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Failure To Run On AC/DC, No Known Impact Or Consequence To Patient, Device Inoperable, Failure to Power Up, Device Displays Incorrect Message, Power Problem, No Audible Prompt/Feedback 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