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CPAP, BiPAP and Ventilators by Philips Recalled 2021

CPAP, BiPAP and Ventilator machines were recalled on June 21, 2021, by Philips Respironics because some models have defective foam containing toxins and particles that may be inhaled into the user’s airway causing serious risks, including cancer.  More alarming news published in the FDA Update, notes that after inspection of Philips’ facilities, digital manuals and staff, the corporation appears to have had years of prior knowledge of the degradation of the noise canceling foam:  FDA Finds Maker of Recalled Sleep Aid Devices Knew Of Problems For Years, But Didn’t Act …

Making matters worse, the Class One recall posed Serious Risks to the consumers and impacted close to 15 million devices. Philips did not have an immediate fix or repair of the defect to help their patients. Some clients complain of shortness of breath that they now believe may have been caused by inhaling foam particulates or toxic gasses into the lungs.

In an FDA inspection of the Philips facilities and documents, the investigators allege that for years there were warnings from inside the company, including at least 14 tests or assessments from 2016, wherein the staff were aware of issues and concerns related to potential foam degradation.  Coming from outside of the walls of the company, there were over 222,000 consumer complaints from 2008 to 2017. However, the FDA said these did not trigger any immediate action from Philips. In fact, the FDA alleges that the Philips executive management team was aware of potential foam degradation as early as January 2020 or earlier, but implemented no corrective action until April 2021.

Philips acknowledged it received a limited number of complaints related to foam degradation over the years and each complaint was evaluated and addressed case by case. Philips users believe the company needs to be held accountable and the lack of communication once they discovered what was wrong with these machines is not right.

Claimants’ lawyers suggest contacting your health care provider and save the machine for inspection, rather than altering or destroying the machine. With over 100 cases filed in many states, the courts have consolidated the cases into one court under cause MDL No. 3014. The potential injuries we are investigating from recalled CPAP and BiPAP and Ventilator users include development or worsening of the following conditions:

  • Asthma
  • Lung cancer
  • COPD/Chronic respiratory illness
  • Pulmonary Hypertension
  • Kidney disease or kidney cancer
  • Shortness of Breath/Difficulty Breathing

CPAP AND BIPAP RECALLED MODELS

(manufactured by Philips between 2009 and April 26, 2021)

Type 1: CPAP and BiLevel PAP

  • Continuous Ventilator, Non-life Supporting
    • C Series ASV, S/T, AVAPS
    • DreamStation ASV
    • DreamStation ST, AVAPS
    • OmniLab Advanced Plus (+)
    • SystemOne ASV4
  • Non-continuous Ventilator
    • Dorma 400, 500 CPAP
    • DreamStation CPAP, Auto CPAP, BiPAP
    • DreamStation Go CPAP, APAP
    • REMStar SE Auto CPAP
    • SystemOne Q series
  • Continuous Ventilator, Minimum Ventilatory Support, Facility Use
  • E30 (Under Emergency Use Authorization)

TYPE 2: MECHANICAL VENTILATORS

  • Continuous Ventilator
    • Garbin Plus, Aeris, LifeVent Ventilator
    • Trilogy 100 Ventilator
    • Trilogy 200 Ventilator
  • Continuous Ventilator, Minimum Ventilatory Support, Facility Use
    • A-Series BiPAP V30 Auto Ventilator
  • Continuous Ventilator, Non-life Supporting
    • A-Series BiPAP V40 Ventilator
    • A-Series BiPAP V30 Ventilator

Philips’ own lab testing of degraded foam particles has revealed the presence of multiple potentially harmful chemicals, including toluene diamine, toluene diisocyanate, and diethylene glycol.

What Is CPAP, BiPAP & Ventilator Litigation?

Certain Philips Respironics sleep apnea machines manufactured between 2009 to 2021were recalled because a polyester based polyurethane foam (PE-PUR) can break down into particles and release toxic chemicals into the machine that can be inhaled and swallowed by the user. The FDA reports these particles or toxic gasses can result in life threatening injuries and require medical treatment to prevent further damage. Major complications include development or worsening of the following medical conditions:

  • Asthma
  • Lung cancer
  • COPD/Chronic respiratory illness
  • Pulmonary Hypertension
  • Kidney disease or kidney cancer
  • Shortness of Breath/Difficulty Breathing

CONTACT US NOW

Call us at 800-814-4540 or fill out the contact form for a free medical legal consultation if you have used a recalled CPAP or BiPAP machine or Ventilator and developed these serious medical conditions or they worsened already existing conditions. There are strict deadlines in each state so contact us NOW.

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