Recall Z-1609-2015 ยท CBK Ventilator, Continuous, Facility Use
Carefusion 211 Inc dba Carefusion
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
| Date | May 26, 2015 (initiated Apr 3, 2015) |
| Status | Terminated |
| Reason | 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 spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator. |
| Root cause | Process control |
| Action | A customer letter dated 4/21/15 will be sent to all customers who received the AVEA Ventilator, all models, to inform them that CareFusion has identified a potential risk associated with AVEA Ventilator caused by a malfunction of a pressure transducer. The malfunctioning pressure transducer is detected and by design ceases ventilation and opens the safety valve to atmosphere allowing spontaneous breathing of patients capable of doing so. The non-breathing patient would need to be manually ventilated. The letter informs the customers of the issues, the potential risk, and the actions to be ta |
| Quantity | 15,905 units total (5,670 units in US) |
| Distribution | Worldwide Distribution. US Nationwide including Guam and Puerto Rico, Canada, Albania, American Samoa, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Belize, Bermuda, Bolivia, Bosnia Herzegovina, Brazil, Bulgaria, Chile, China (Peoples Rep), Colombia, Costa Rica, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103211 | AVEA VENTILATOR Care Fusion, May 12, 2011 |