FDA recently assigned a Class I designation to a voluntary recall at BD's CareFusion involving 501 AVEA ventilators.
The ventilators—made between November 13, 2015 and January 4, 2016, and distributed between December 16, 2015 and February 15, 2016—have an incorrect F1 fuse on the transducer communication alarm board, according to CareFusion. The incorrect fuse on the TCAboards, which were made by Jabil for CareFusion, could cause the board to fail or blow, cutting off power to the user interface module and ceasing ventilation.
Cutting off ventilation to a patient who needs it could seriously injure or kill them. Fortunately, CareFusion has received zero complaints about the potentially faulty board fuses.
After discovering the problem, CareFusion alerted its healthcare customers in May, requesting that they identify affected ventilators and send a response card so that the company could arrange for onsite fixes of the devices.
Ventilators overall are frequent targets of Class I recalls, andAVEA ventilators have had problems in the past. A Class I–level recall in 2013 involved device sensor problems in high altitudes.
Needless to say, failing ventilators can be potentially life threatening for patients unable to breath without assistance. Ventilator recalls in the past have included everything from software glitches to defective electronic components to power management to cracked connectors.