FDA Disapproves CPAP Machines

For years, CPAP machines have been used by sleep apnea patients to help them breathe while sleeping. However, controversies have been going on in recent times related to these machines after the FDA disapproved some of them. Anyone who has been affected by these machines can get legal help for CPAP injuries by filing a lawsuit. 

Why the FDA disapproves CPAP

In April 2021, Philips recalled millions of CPAPs, Bi-PAP machines, and mechanical ventilators due to a design defect in them that could prove fatal to humans. All of these machines contain a foam material known as polyester-based polyurethane (PE-PUR). 

This foam is present in the machine to reduce sound and vibration for a disturbance-free experience. When these machines are used, this foam degrades into microparticles and emits harmful chemicals. Upon inhaling and swallowing these, a person can fall severely sick and potentially get cancer. 

PE-PUR foam emits toxic, carcinogenic chemicals: toluene diisocyanate, dimethyl diazene, diethylene glycol, phenol, 2,6-bis, and toluene diamine. Users have also reported seeing debris in their masks and breathing tubes which is evidence of foam degradation. 

The FDA recognizes the threats and scope of these machines and has thus disapproved of the usage of the recalled machines. Therefore, if you have one at your home, it’s best to discontinue using it and consult a doctor. 

Furthermore, if these devices are kept in humid areas, the hot temperature and environmental conditions can degrade the foam too. Therefore, sleep apnea patients living in humid areas cannot use this device. 

This has been identified by the FDA as Class I recall, the most severe type of recall. Usage of these machines can cause death in humans.

Here’s a list of all the devices disapproved by the FDA and recalled by Philips.

  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne (Q series)
  • E30 (Emergency Use Authorization)
  • Dorma 400, 500 CPAP
  • Garbin Plus, Aeris, LifeVent Ventilator
  • C Series ASV, S/T, AVAPS
  • SystemOne ASV4
  • DreamStation CPAP, Auto CPAP, BiPAP
  • Trilogy 100 Ventilator
  • REMStar SE Auto CPAP
  • OmniLab Advanced Plus In-Lab Titration Device
  • DreamStation GO CPAP, APAP
  • A-Series BiPAP V30 Auto Ventilator
  • Trilogy 200 Ventilator

Possible health hazards

Victims have reported various diseases.

  • Brain/lung/liver/kidney/prostate cancer
  • Respiratory failure
  • Bronchitis
  • Pneumonia
  • Reactive Airway Disease (RAD)
  • Heart attack/ heart failure
  • Stroke
  • Kidney failure
  • Lung failure
  • Leukemia
  • Inhalation injury

What you should do

If using Philips’ machine has harmed you, consult your doctor today and document your injury. This will serve as proof in your lawsuit. Contact the Shouse Injury Law Group to discuss if you qualify for a lawsuit and find the best lawyer who will seek you the best compensation. 

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