MAUDE manufacturer profile

DRAEGER MEDICAL SYSTEMS, INC · LBI

MAUDE profile for Unit, Neonatal Phototherapy

Key facts

Manufacturer DRAEGER MEDICAL SYSTEMS, INC
Manufacturer group DRAEGER MEDICAL SYSTEMS, INC
Product code LBI
Product code name Unit, Neonatal Phototherapy

At a glance

  • 10–99 MAUDE reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Clinical Signs, Symptoms or Conditions, Device Dislodged or Dislocated, Detachment of Device or Device Component, Device Fell, Structural Problem, Unstable, Use of Device Problem, No Device Output 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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