MAUDE brand profile
CONCDEMO UNIT FIOH2SHOW HFII
MAUDE brand safety profile
Key facts
| Brand name | CONCDEMO UNIT FIOH2SHOW HFII |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, Device Alarm System, No Information, Device Displays Incorrect Message, Device Operates Differently Than Expected, Device Inoperable, Defective Alarm, Loss of Power 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