MAUDE manufacturer profile

SMITHS MEDICAL · MEA

MAUDE profile for Pump, Infusion, Pca

Key facts

Manufacturer SMITHS MEDICAL
Product code MEA
Product code name Pump, Infusion, Pca

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, Device Alarm System, Insufficient Information, No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, Failure to Infuse, No Consequences Or Impact To Patient, Detachment of Device or Device Component 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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