On June 14, 2021, Philips Respironics issued a voluntary medical device recall for millions of its CPAP devices, BiPAP devices, and mechanical ventilators. Specifically, the following CPAP and BiPAP devices were recalled: E30, DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+, SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto. Philips has also issued a recall for the following ventilators: Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent, BiPAP V30, and BiPAP A30/A40 Series Device Models. The recall encompasses all serial numbers of these devices manufactured between 2009 and April 26, 2021.
The recall is due to two issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators. First, the PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user. Second, the PE-PUR foam may emit certain chemicals that could be inhaled. Research and testing done by Philips Respironics indicates that the breakdown is primarily caused by the devices being used in high heat and high humidity environments or using unapproved cleaning methods such as ozone. Philips has also indicated that breakdown is more likely to occur in devices that are more than three years old.
The PE-PUR foam is generally not harmful if it remains intact. However, if the foam breaks down, it can release particles and chemical gases which can be harmful to someone using the device. Break down of the foam may result in particles and chemicals being released into the device’s air pathway which the user may inhale or swallow. Even if there are no visible particles, the foam could be releasing harmful chemicals which are then inhaled. Philips discovered emissions of two toxic gases, dimethyl diazine and Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl)-, that exceeded the safe exposure threshold during laboratory testing. The potential risks of particulate and chemical exposure include irritation to eyes, skin and respiratory tract as well as inflammatory response, headache, asthma, adverse effects to other organs such as the kidney and liver as well as other toxic or carcinogenic effects. To date, Philips has received complaints about the presence of black debris/particles within the device’s air pathway. Philips has also received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. However, there have been no reports of death as a result of these issues.
The FDA has identified this as a Class I recall which is the most serious type of recall. The FDA is continuing to work with the company to assure it has sufficient evidence to support the Philips Respironics recall strategy, including its corrective actions. As a medical device manufacturer, Philips Respironics is responsible for ensuring the manufacture of safe and effective devices as well as establishing an appropriate mitigation strategy to reduce public harm in the event of device failure or defect. Philips has indicated that it will replace the current insulation foam with new material. A timeframe for device replacement has not yet been set. The FDA is currently reviewing the information Philips Respironics has provided regarding replacement devices while continuing to work with Philips Respironics on their corrective actions for existing devices. The FDA will then determine whether the proposed replacement devices pose any additional risk to people who use these devices.
If you are currently using one of the recalled devices, it is important to consult with your doctor immediately to determine whether it is appropriate to discontinue use at this time and what the next steps in your treatment should be. You should also register your device at https://www.usa.philips.com/healthcare/e/sleep/communications/src-update.
