Modification to Avea Ventilator

12 recalls, same reason

• Terminated Z-1894-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1888-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1892-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1897-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1895-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1896-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1898-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1899-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1889-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1890-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1893-2016 FDA Class I ·initiated 17 May 2016
• Terminated Z-1891-2016 FDA Class I ·initiated 17 May 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 loss of power to the User Interface Module (UIM).

• Terminated Z-2273-2013 FDA Class I ·initiated 5 Sep 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. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.

• Terminated Z-0510-2012 FDA Unclassified (pre-2012) ·initiated 8 Sep 2011

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. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.