MAUDE manufacturer profile
HEARTWARE, INC. · DSQ
MAUDE profile for Ventricular (Assist) Bypass
Key facts
| Manufacturer | HEARTWARE, INC. |
|---|---|
| Manufacturer group | HEARTWARE, INC. |
| Product code | DSQ |
| Product code name | Ventricular (Assist) Bypass |
At a glance
- 1,000+ MAUDE reports
- 1,000+ Death reports
- 1,000+ Injury reports
- 1,000+ Malfunction reports
- 100–999 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Known Impact Or Consequence To Patient, No Clinical Signs, Symptoms or Conditions, Battery Problem, No Consequences Or Impact To Patient, Pumping Problem, Blood Loss, Power 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