Device product
Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in adults with acute respiratory failure or acute cardiopulmonary failure Product Code: F30000163
Z-1822-2024
Product summary
- Event
- Event 94393
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 88 units
- Official record key
device-enforcement:Z-1822-2024
Official wording
Reason: Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.
Code information: UDI-DI: 4057224 (+ serial number) Serial Numbers:XCONUS0001 to XCONUS0124
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Issue related to Novalung sensor box, which is a component of the Novalung Console (Part Number F30000163). In certain instances, error messages #206 (yellow) and #208 (red) technical failure, flow measurement during use of the Novalung system.