MAUDE manufacturer profile

MAQUET CARDIOPULMONARY GMBH · KFM

MAUDE profile for Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Key facts

Manufacturer MAQUET CARDIOPULMONARY GMBH
Manufacturer group JULIA KAPFENBERGER
Product code KFM
Product code name Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

At a glance

  • 1,000+ MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1,000+ Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Electrical /Electronic Property Problem, Device Displays Incorrect Message, Pumping Stopped, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Battery Problem, No Patient Involvement 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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