MAUDE brand profile
FUSION EM SYSTEM
MAUDE brand safety profile
Key facts
| Brand name | FUSION EM SYSTEM |
|---|
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems coded
- 1–9 Problems flagged by Orca1 signal analytics
- No Patient Involvement, Human-Device Interface Problem, Mechanical Problem, Computer Software Problem, No Clinical Signs, Symptoms or Conditions, Device Sensing Problem, Electromagnetic Interference, No Known Impact Or Consequence To Patient 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