MAUDE manufacturer profile
ORGANOX LIMITED · QQK
MAUDE profile for Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation
Key facts
| Manufacturer | ORGANOX LIMITED |
|---|---|
| Manufacturer group | INTEGRATED TECHNOLOGIES LTD |
| Product code | QQK |
| Product code name | Normothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To Transplantation |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Liver Damage/Dysfunction, Physical Resistance/Sticking, Restricted Flow rate, Insufficient Information, Premature Discharge of Battery, Low Blood Pressure/ Hypotension, 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