MAUDE brand profile
OARM 1000 IMAGING SYSTEM 3RD EDITION
MAUDE brand safety profile
Key facts
| Brand name | OARM 1000 IMAGING SYSTEM 3RD EDITION |
|---|
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Patient Involvement, No Clinical Signs, Symptoms or Conditions, Device Operates Differently Than Expected, Application Program Freezes, Becomes Nonfunctional, No Known Impact Or Consequence To Patient, Electrical /Electronic Property Problem, No Consequences Or Impact To Patient, Device Displays Incorrect Message 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