MAUDE manufacturer profile
ICU MEDICAL. INC. · NEP
MAUDE profile for System/Device, Pharmacy Compounding
Key facts
| Manufacturer | ICU MEDICAL. INC. |
|---|---|
| Manufacturer group | ICU MEDICAL, INC. |
| Product code | NEP |
| Product code name | System/Device, Pharmacy Compounding |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Inaccurate Delivery, Material Deformation, Fracture, Device Operates Differently Than Expected, Break, Application Program Problem: Dose Calculation Error, Elevated ketones/Diabetic Ketoacidosis 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