# K103211: Avea Ventilator - Pathway: 510(k) (Traditional) - Applicant: Care Fusion - Decided: May 12, 2011 after 192 days - Product code: CBK (Ventilator, Continuous, Facility Use) - Device class: 2 - Regulation: 21 CFR 868.5895 - Recalls of this device: 15 (14 Class I) - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 12 generations back to K902859 (1991). 73 ancestors in all. 5 later devices descend from it; 2 cite it directly. 11 of 79 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K083693: PB 840 Ventilator System with Leak Compensation Option, Model 840, Covidien, Formerly Nellcor Puritan Bennett, Inc. (2009) Summary page 1. - K974176: Babylog 8000 Plus, Drager, Inc. (1998) Summary page 1. ## Most influential descendants - K131252: Puritan Bennett 980 Series Ventilator System (2014), 2 descendants of its own - K162738: Puritan Bennett 980 Ventilator System (2017), 1 descendant of its own - K162832: 731 Series Ventilators (2017), 1 descendant of its own - K233486: 731 Series Ventilator (2024), 0 descendants of its own - K193056: Puritan Bennett 980 Series Ventilator System (2020), 0 descendants of its own ## Recalls of this device - May 17, 2016 · Class I · Z-1888-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1895-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1896-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1899-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1892-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1897-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1898-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1894-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1889-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1891-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1890-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - May 17, 2016 · Class I · Z-1893-2016: CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing - Apr 3, 2015 · Class I · Z-1609-2015: A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spo - Sep 5, 2013 · Class I · Z-2273-2013: CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. Ca - Sep 8, 2011 · Not classified · Z-0510-2012: The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011 ## Indications for use The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Source page: https://510kreport.com/device/K103211 Methodology: https://510kreport.com/methodology