MAUDE manufacturer profile

COVIDIEN LLC · OLW

MAUDE profile for Index-Generating Electroencephalograph Software

Key facts

Manufacturer COVIDIEN LLC
Manufacturer group COVIDIEN LLC
Product code OLW
Product code name Index-Generating Electroencephalograph Software

At a glance

  • 10–99 MAUDE reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Incorrect Measurement, Insufficient Information, Communication or Transmission Problem, Temperature Problem, Material Split, Cut or Torn, Device Damaged Prior to Use, Device Alarm System 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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