MAUDE manufacturer profile

PULSION MEDICAL SYSTEMS SE · KRB

MAUDE profile for Probe, Thermodilution

Key facts

Manufacturer PULSION MEDICAL SYSTEMS SE
Manufacturer group PULSION MEDICAL SYSTEMS SE
Product code KRB
Product code name Probe, Thermodilution

At a glance

  • 100–999 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 100–999 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Leak/Splash, No Consequences Or Impact To Patient, No Known Impact Or Consequence To Patient, Material Fragmentation, Adverse Event Without Identified Device or Use Problem, Fluid/Blood Leak, Crack 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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