MAUDE manufacturer profile

PHYSIO-CONTROL, INC. - 3015876 · DRX

MAUDE profile for Electrode, Electrocardiograph

Key facts

Manufacturer PHYSIO-CONTROL, INC. - 3015876
Manufacturer group PHYSIO-CONTROL, INC. - 3015876
Product code DRX
Product code name Electrode, Electrocardiograph

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Failure to Sense, Device Sensing Problem, No Known Impact Or Consequence To Patient, Failure to Deliver Shock/Stimulation, Connection Problem, Asystole, Burn(s) 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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