MAUDE manufacturer profile
SPECTRUM MEDICAL LTD · DTQ
MAUDE profile for Console, Heart-Lung Machine, Cardiopulmonary Bypass
Key facts
| Manufacturer | SPECTRUM MEDICAL LTD |
|---|---|
| Manufacturer group | SPECTRUM MEDICAL LTD |
| Product code | DTQ |
| Product code name | Console, Heart-Lung Machine, Cardiopulmonary Bypass |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Pumping Stopped, Pumping Problem, Damaged Thread, Mechanical Problem, Infusion or Flow Problem, Insufficient Information, Failure to Pump 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