MAUDE manufacturer profile

VYAIRE OY · BTL

MAUDE profile for Ventilator, Emergency, Powered (Resuscitator)

Key facts

Manufacturer VYAIRE OY
Manufacturer group VYAIRE OY
Product code BTL
Product code name Ventilator, Emergency, Powered (Resuscitator)

At a glance

  • 1–9 MAUDE reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Material Integrity Problem, Insufficient Information, No Clinical Signs, Symptoms or Conditions 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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