AVEA 12283-PMNRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10846446064865), received between Sep 6, 2020 and Sep 6, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

15 other recalls cover devices cleared under the same FDA submission (K103211); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 6, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED UNIT IS ALARMING HIGH FIO2 FOR AVEA UNIT. AT THIS TIME, THERE IS NO INFORMATION REGARDING PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Information

  MAUDE report 10498367 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103211. One submission often covers many models, so check the product and lot details in each record.

• Z-1891-2016 · May 17, 2016 · Terminated
  AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering
• Z-1897-2016 · May 17, 2016 · Terminated
  Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined per
• Z-1895-2016 · May 17, 2016 · Terminated
  Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predeterm
• Z-1892-2016 · May 17, 2016 · Terminated
  AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a pred
• Z-1894-2016 · May 17, 2016 · Terminated
  TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the brea
• Z-1896-2016 · May 17, 2016 · Terminated
  Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of ox
• Z-1893-2016 · May 17, 2016 · Terminated
  AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by d
• Z-1899-2016 · May 17, 2016 · Terminated
  AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxyg
• Z-1888-2016 · May 17, 2016 · Terminated
  AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predeter
• Z-1898-2016 · May 17, 2016 · Terminated
  AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of
• Z-1890-2016 · May 17, 2016 · Terminated
  AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering
• Z-1889-2016 · May 17, 2016 · Terminated
  AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined
• Z-1609-2015 · Apr 3, 2015 · Terminated
  CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predeterm
• Z-2273-2013 · Sep 5, 2013 · Terminated
  Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A cont
• Z-0510-2012 · Sep 8, 2011 · Terminated
  AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It