MAUDE manufacturer profile

MAQUET CARDIOPULMONARY GMBH · DWC

MAUDE profile for Controller, Temperature, Cardiopulmonary Bypass

Key facts

Manufacturer MAQUET CARDIOPULMONARY GMBH
Manufacturer group JULIA KAPFENBERGER
Product code DWC
Product code name Controller, Temperature, Cardiopulmonary Bypass

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Patient Involvement, Device Displays Incorrect Message, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Temperature Problem, Device Operates Differently Than Expected, Insufficient Heating, Insufficient Cooling 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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