MAUDE manufacturer profile
SPECTRUM MEDICAL LTD · DTX
MAUDE profile for Gas Control Unit, Cardiopulmonary Bypass
Key facts
| Manufacturer | SPECTRUM MEDICAL LTD |
|---|---|
| Manufacturer group | SPECTRUM MEDICAL LTD |
| Product code | DTX |
| Product code name | Gas Control Unit, Cardiopulmonary Bypass |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Gas Output Problem, Suction Problem, Device Sensing Problem, Suction Failure, Infusion or Flow Problem, Inaccurate Delivery, Output 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