MAUDE manufacturer profile
RESPIRONICS, INC. · OLV
MAUDE profile for Standard Polysomnograph With Electroencephalograph
Key facts
| Manufacturer | RESPIRONICS, INC. |
|---|---|
| Manufacturer group | RESPIRONICS, INC. |
| Product code | OLV |
| Product code name | Standard Polysomnograph With Electroencephalograph |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Circuit Failure, Degraded, Eye Irritation, Skin Inflammation/ Irritation, Unintended Electrical Shock, Unspecified Respiratory Problem, Nausea 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