MAUDE manufacturer profile

NIHON KOHDEN CORPORATION · MHX

MAUDE profile for Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Key facts

Manufacturer NIHON KOHDEN CORPORATION
Manufacturer group NIHON KOHDEN TOMIOKA CORPORATION
Product code MHX
Product code name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, No Known Impact Or Consequence To Patient, Communication or Transmission Problem, Output Problem, No Consequences Or Impact To Patient, Application Program Problem, Display or Visual Feedback Problem, Unintended Application Program Shut Down 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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