MAUDE manufacturer profile
SALTER LABS · KGB
MAUDE profile for Mask, Oxygen, Non-Rebreathing
Key facts
| Manufacturer | SALTER LABS |
|---|---|
| Manufacturer group | SALTER LABS DE MEXICO DE S.A. DE C.V. |
| Product code | KGB |
| Product code name | Mask, Oxygen, Non-Rebreathing |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Device Slipped, Improper Flow or Infusion, Material Separation, Connection Problem, Patient Device Interaction Problem, Device Displays Incorrect Message, Low Oxygen Saturation, Confusion/ Disorientation 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