Avea™ 63865

• FDA 510(k) K103211 decided 12 May 2011 Active
• FDA GUDID UDI-DI 10190752175921 listed 9 Mar 2021 Listed

• 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-1609-2015 FDA Class I ·initiated 3 Apr 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 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.

• • 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.

1. 17 May 2016 Recall initiated FDA recalls Z-1897-2016
2. 17 May 2016 Recall initiated FDA recalls Z-1895-2016
3. 17 May 2016 Recall initiated FDA recalls Z-1896-2016
4. 17 May 2016 Recall initiated FDA recalls Z-1898-2016
5. 17 May 2016 Recall initiated FDA recalls Z-1899-2016
6. 17 May 2016 Recall initiated FDA recalls Z-1889-2016
7. 17 May 2016 Recall initiated FDA recalls Z-1890-2016
8. 17 May 2016 Recall initiated FDA recalls Z-1893-2016
9. 17 May 2016 Recall initiated FDA recalls Z-1891-2016
10. 9 Mar 2021 Listed FDA GUDID 10190752175921

7 earlier events are in the sections above.

Trade name

Avea™

Generic name

Ventilator application software

Model / Ref / Catalog

63865

Primary DI / UDI-DI

10190752175921

510(k) Number

K103211 ↗

FDA product code

CBK

GMDN term

Ventilator application software

Device class

Class II

Regulation number

868.5895

GUDID distribution status

In Commercial Distribution

Category: Ventilator application software

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• GE DATEX-OHMEDA CENTIVA/5 VENTILATOR by Datex-Ohmeda Inc.
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• HAMILTON-C2 by Hamilton Medical AG

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  Class II

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• 3100B Hfov 11744-Hrck

  Class III

  FDA PMA P890057 Active Approved 29 Mar 1991 GUDID on market

• Infant Flow™ 777000M

  Class II

  FDA 510(k) K031745 Active Cleared 13 Feb 2004 GUDID on market

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