MAUDE manufacturer profile

MAQUET CARDIOPULMONARY GMBH · DWE

MAUDE profile for Tubing, Pump, Cardiopulmonary Bypass

Key facts

Manufacturer MAQUET CARDIOPULMONARY GMBH
Manufacturer group JULIA KAPFENBERGER
Product code DWE
Product code name Tubing, Pump, Cardiopulmonary Bypass

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Known Impact Or Consequence To Patient, Fluid/Blood Leak, Device Operates Differently Than Expected, No Clinical Signs, Symptoms or Conditions, Leak/Splash, No Consequences Or Impact To Patient, Death, Improper Flow or Infusion 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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