MAUDE manufacturer profile
SMITHS MEDICAL INTERNATIONAL, LTD. · FRN
MAUDE profile for Pump, Infusion
Key facts
| Manufacturer | SMITHS MEDICAL INTERNATIONAL, LTD. |
|---|---|
| Product code | FRN |
| Product code name | Pump, Infusion |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Displays Incorrect Message, No Consequences Or Impact To Patient, No Clinical Signs, Symptoms or Conditions, Device Operates Differently Than Expected, Device Alarm System, No Information, Failure to Infuse 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