MAUDE manufacturer profile

GALWAY · CBK

MAUDE profile for Ventilator, Continuous, Facility Use

Key facts

Manufacturer GALWAY
Manufacturer group GALWAY
Product code CBK
Product code name Ventilator, Continuous, Facility Use

At a glance

  • 1–9 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Computer Operating System Problem, Device Displays Incorrect Message, Output Problem, Device Inoperable, No Clinical Signs, Symptoms or Conditions, No Display/Image, No Flow 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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