MAUDE manufacturer profile

EDWARDS LIFESCIENCES DR · DXN

MAUDE profile for System, Measurement, Blood-Pressure, Non-Invasive

Key facts

Manufacturer EDWARDS LIFESCIENCES DR
Manufacturer group EDWARDS LIFESCIENCE
Product code DXN
Product code name System, Measurement, Blood-Pressure, Non-Invasive

At a glance

  • 100–999 MAUDE reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Incorrect Measurement, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Unspecified Tissue Injury, No Apparent Adverse Event, Low Blood Pressure/ Hypotension 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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