MAUDE manufacturer profile

FISHER & PAYKEL HEALTHCARE LTD · BZE

MAUDE profile for Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Key facts

Manufacturer FISHER & PAYKEL HEALTHCARE LTD
Manufacturer group FISHER & PAYKEL HEALTHCARE LTD
Product code BZE
Product code name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Leak/Splash, Crack, Gas/Air Leak, No Patient Involvement, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Break 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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