MAUDE manufacturer profile

NIHON KOHDEN CORPORATION · DPS

MAUDE profile for Electrocardiograph

Key facts

Manufacturer NIHON KOHDEN CORPORATION
Manufacturer group NIHON KOHDEN TOMIOKA CORPORATION
Product code DPS
Product code name Electrocardiograph

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Output Problem, Incorrect Measurement, No Known Impact Or Consequence To Patient, Connection Problem, Failure to Power Up, Battery 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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