MAUDE manufacturer profile

FISHER & PAYKEL HEALTHCARE LTD · BTL

MAUDE profile for Ventilator, Emergency, Powered (Resuscitator)

Key facts

Manufacturer FISHER & PAYKEL HEALTHCARE LTD
Manufacturer group FISHER & PAYKEL HEALTHCARE LTD
Product code BTL
Product code name Ventilator, Emergency, Powered (Resuscitator)

At a glance

  • 1,000+ MAUDE reports
  • 1–9 Death reports
  • 1–9 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Break, Pressure Problem, No Patient Involvement, No Known Impact Or Consequence To Patient, Device Issue, No Consequences Or Impact To Patient, Output 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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