Philips CPAP Issues

For over a decade, Philips sold CPAP (continuous positive airway pressure) machines that Americans used to manage their sleep apnea. A recent recall has revealed that these devices contained dangerous materials that can cause serious harm to users. Philips continued to sell these devices with potentially dangerous materials to the general public until recalls were issued in 2021. If you used one of the following types of models of Philips devices, and it was manufactured before April 26, 2021, your CPAP device is affected by this recall:

  • DreamStation
  • DreamStation models: Go, ASV, ST, AVAPS
  • SystemOne models: ASV4, Q-Series, 50, 60
  • C-Series models: ASV, S/T, AVAPS
  • OmniLab AdvancedPlus

In these devices, Philips used polyester-based polyurethane foam (“PE-PUR”) to absorb sound created while the CPAP device operates. This foam is not essential for the CPAP to work, and Philips now uses silicone-based foam in new and refurbished CPAP devices. This foam degrades with time, exposure to humidity, and exposure to heat. As the foam degrades, small particles may disintegrate, and the foam can produce “off-gassing,” where the volatile organic compounds (VOCs) contained in the foam leak into the air. Because CPAPs direct pressurized air into the airway of people using them, people may ingest or inhale particles of this foam or the off-gassing the foam emits. This problem causes black debris or particles to appear in the mask, tubing, outlet, and humidifier of an affected CPAP device.

Potential symptoms of exposure to PE-PUR particles include irritation of the eyes, skin, and respiratory tract, headaches, and asthma. Off-gassing exposure causes the same symptoms, and can also cause nasal irritation, hypersensitivity, dizziness, and nausea or vomiting. Philips has even stated that the degradation and off-gassing from PE-PUR sound-abatement foam “can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.” These may include toxic or carcinogenic (cancer-causing) effects, and adverse effects on organs like the kidneys or liver.

The FDA inspected Philips Respironics’ manufacturing facility and issued a 28-page report on November 12, 2021.  In that report, the FDA criticized Philips’ “investigation, health hazard evaluation, risk analysis, or design review” of devices with PE-PUR.  The FDA noted that “there were at least fourteen instances, assessments, and/or test reports, dated from 04/01/2016 to 01/22/2021, where [Philips] was aware of issues and concerns related to potential foam degradation and/or Volatile Organic Compound (VOC) emissions” with affected devices.

If you or someone you know has been diagnosed with cancer, liver or kidney damage, worsening respiratory conditions, or even heart attacks and death, and you believe it may be related to use of a Philips Respironics CPAP, APAP, or BiPAP machine, you are not alone. You may be entitled to recover compensation for your injuries. Contact us for a free consultation.

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