The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. These Philips Trilogy 100 and Trilogy 2000 ventilators were a part of this recall in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Trilogy 100 and Trilogy 200 ventilators. CPAP machines are often prescribed to people with obstructive sleep apnea to keep their airways open during sleep. A CPAP machine keeps your airway open by providing a stream of air at a continuous pressure through a mask.These devices are also prescribed to people with obstructive sleep apnea to keep their airways open during sleep. BiPAP machines use a higher pressure when you breathe in and lower pressure when you breathe out. A BiPAP machine pumps air under varying pressure into the airway of the lungs.A continuous ventilator mechanically controls or helps patients' breathing while delivering a set amount of oxygen.Three types of devices have been recalled: Philips also recalled certain Trilogy Evo ventilators distributed from Apto with specific serial numbers. Garbin Plus, Aeris, LifeVent (ventilator). Philips recalled the following devices made between 2009 and April 26, 2021: If you use one of these recalled devices, follow the recommendations listed below. The PE-PUR foam issue may result from exposure to hot and humid conditions and may be exacerbated by the use of ozone cleaners or other cleaning methods not recommended by the manufacturer. These issues could potentially result in serious injury and require medical intervention to prevent permanent injury. If this occurs, black pieces of foam, or certain chemicals that are not visible, could be breathed in or swallowed by the person using the device. The polyester-based polyurethane (PE-PUR) foam used in these devices to reduce sound and vibration can break down. In June 2021, Philips recalled certain ventilators, BiPAP machines, and CPAP machines (see table below) because of potential health risks.
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