MAUDE manufacturer profile
NELLCOR PURITAN BENNETT IRELAND · DQA
MAUDE profile for Oximeter
Key facts
| Manufacturer | NELLCOR PURITAN BENNETT IRELAND |
|---|---|
| Manufacturer group | NELLCOR PURITAN BENNETT IRELAND |
| Product code | DQA |
| Product code name | Oximeter |
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Device Alarm System, No Patient Involvement, Display or Visual Feedback Problem, Low Readings, Image Display Error/Artifact, High Readings, Death 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