MAUDE manufacturer profile
AVERTIX MEDICAL INC. · QBI
MAUDE profile for Acute Coronary Syndrome Event Detector
Key facts
| Manufacturer | AVERTIX MEDICAL INC. |
|---|---|
| Manufacturer group | AVERTIX MEDICAL INC |
| Product code | QBI |
| Product code name | Acute Coronary Syndrome Event Detector |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- Failure of Implant, Premature Discharge of Battery, No Clinical Signs, Symptoms or Conditions, Bacterial Infection, Detachment of Device or Device Component, Battery Problem, Insufficient Information, Adverse Event Without Identified Device or Use Problem 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