MAUDE manufacturer profile
SMITHS MEDICAL INTERNATIONAL, LTD. · BTM
MAUDE profile for Ventilator, Emergency, Manual (Resuscitator)
Key facts
| Manufacturer | SMITHS MEDICAL INTERNATIONAL, LTD. |
|---|---|
| Product code | BTM |
| Product code name | Ventilator, Emergency, Manual (Resuscitator) |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Device Alarm System, Physical Resistance/Sticking, Gas/Air Leak, Endocarditis, Insufficient Information, No Known Impact Or Consequence To Patient, Missing Information 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