MAUDE manufacturer profile

BERLIN HEART GMBH · DSQ

MAUDE profile for Ventricular (Assist) Bypass

Key facts

Manufacturer BERLIN HEART GMBH
Manufacturer group BERLIN HEART GMBH
Product code DSQ
Product code name Ventricular (Assist) Bypass

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, No Consequences Or Impact To Patient, Output Problem, Hemolysis, No Clinical Signs, Symptoms or Conditions, Ischemia Stroke, Fluid/Blood Leak, Ischemia 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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