MAUDE manufacturer profile
MASIMO CORPORATION · GWQ
MAUDE profile for Full-Montage Standard Electroencephalograph
Key facts
| Manufacturer | MASIMO CORPORATION |
|---|---|
| Manufacturer group | INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C.V. |
| Product code | GWQ |
| Product code name | Full-Montage Standard Electroencephalograph |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Incorrect Measurement, Device Sensing Problem, Display or Visual Feedback Problem, Device Stops Intermittently, False Reading From Device Non-Compliance, Signal Artifact/Noise 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