MAUDE manufacturer profile
MEDTRONIC NAVIGATION, INC (LITTLETON) · OXO
MAUDE profile for Image-Intensified Fluoroscopic X-Ray System, Mobile
Key facts
| Manufacturer | MEDTRONIC NAVIGATION, INC (LITTLETON) |
|---|---|
| Manufacturer group | MEDTRONIC NAVIGATION, INC (LITTLETON) |
| Product code | OXO |
| Product code name | Image-Intensified Fluoroscopic X-Ray System, Mobile |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Device Operates Differently Than Expected, Electrical /Electronic Property Problem, Application Program Freezes, Becomes Nonfunctional, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Device Displays Incorrect Message 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