Philips Respironics voluntarily recalled more than 3.5 million of their ventilators and CPAP and BiPAP machines after evidence indicated that a polyester-based urethane (PE-PUR) foam used to reduce sound and vibration in the devices might break down into particles that could enter the machine’s air pathway. PE-PUR can degrade into black particles that can lead to serious medical conditions when inhaled or swallowed by the patient.
While research is still developing, patients have reported “CPAP headaches”, heart or respiratory failure, heart attack, or stroke. Additionally, others have noted the following:
Injuries Still Present Without Foam Degradation
Many users have reported discovering black particles in their Philips DreamStation or CPAP machines. Even if there is no visible debris is present, foam degradation can expose users to toxic substances known to raise the risk of serious or life-threatening health conditions, such as:
According to Phillips, most of the affected machines are in the first-generation DreamStation product line first introduced in October 2015, including the Trilogy ventilators, A-series BiPAP machines, C-series BiPAP machines, OmniLab Advanced+, Garbin Plus, Aeris, LifeVen, E30 ventilator, REMstar SE Auto, and E30. Most of the recalled devices were purchased five years before the recall and are still considered within the expected life cycle of the machines. Owners of the affected devices have been advised to stop using their machines immediately and speak with healthcare providers about treatment alternatives.
Philips CPAP Foam Degradation Lawsuits Being Filed
Product liability lawsuits are being pursued by people who may have been exposed to toxic particles and chemicals released by degraded sound abatement foam used in certain Philips DreamStation, CPAP, BiPAP, and mechanical ventilators that were manufactured and sold between 2009 and 2021.
The FDA has suggested reporting the issue with the machine to the product website, however, we are uncertain what benefit there would be to doing so. Give us a call at Childers, Schlueter & Smith if you have been diagnosed with a severely injured after using the Philips Respironics CPAP, BiPAP machines or ventilators. You can also use our contact us page to tell us your concerns.