MAUDE brand profile
OARM O2 IMAGING SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | OARM O2 IMAGING SYSTEM |
|---|
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Application Program Freezes, Becomes Nonfunctional, No Patient Involvement, Device Operates Differently Than Expected, Positioning Problem, Radiation Output Failure, No Known Impact Or Consequence To Patient, Failure to Advance Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1