MAUDE manufacturer profile

MEDTRONIC NAVIGATION, INC · OXO

MAUDE profile for Image-Intensified Fluoroscopic X-Ray System, Mobile

Key facts

Manufacturer MEDTRONIC NAVIGATION, INC
Manufacturer group MEDTRONIC NAVIGATION, INC
Product code OXO
Product code name Image-Intensified Fluoroscopic X-Ray System, Mobile

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
  • Application Program Freezes, Becomes Nonfunctional, No Patient Involvement, No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Positioning Problem, Unexpected Shutdown, Failure to Charge, Device Sensing 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

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