Philips Respironics CPAP, BiPAP & Ventilator Recall
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Philips Respironics CPAP, BiPAP & Ventilator Recall
On June 14, 2021, Philips Respironics issued a Class I recall of numerous CPAP, BiPAP, and ventilator machines due to serious potential health concerns including the risk of cancer and respiratory complications. A Class I recall is the most significant and urgent type of FDA recall which pertains to defective products that can lead to serious injury or death. In the recall notice, Philips Respironics warned that the polyester-based polyurethane (PE-PUR) sound abatement foam used to reduce sound and vibration within the ventilation machines may break down and potentially enter the device’s air pathway. When this occurs, debris and toxic chemicals emanating from the foam may be inhaled or swallowed by the patient causing serious injury.
Which Philips Respironics CPAP/BiPAP/Ventilator Machines Have Been Recalled?
Philips Respironics’ Class 1 recall affects the following CPAP, BiPAP and ventilator machines manufactured prior to April 26, 2021:
- A-Series BiPAP A30
- A-Series BiPAP A40
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30
- A-Series BiPAP V30 Auto
- C-Series ASV
- C-Series S/T
- C-Series AVAPS
- Dorma 400 CPAP
- Dorma 500 CPAP
- DreamStation ASV
- DreamStation Auto CPAP
- DreamStation AVAPS
- DreamStation BiPAP
- DreamStation CPAP
- DreamStation ST
- DreamStation GO APAP
- DreamStation GO CPAP
- E30 Continuous Ventilator
- Garbin Aeris Ventilator
- Garbin LifeVent Ventilator
- Garbin Plus Ventilator
- OmniLab Advanced Plus In-Lab Titration Device
- REMStar SE Auto CPAP
- SystemOne ASV4
- SystemOne Q Series
- Trilogy 100 Ventilator
- Trilogy 200 Ventilator
The above ventilation machines were distributed by Philips Respironics in the U.S. from November 5, 2005 to April 23, 2021.
Please note that the above list may be updated if the recall notification is expanded to include additional devices or as new information is learned during the course of litigation.
Injuries Associated with Philips Respironics CPAP, BiPAP and Ventilator Machines
On June 30, 2021, the United States Food and Drug Administration (FDA) warned that the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Respironics ventilation machines may:
- Break down into particles which may enter the device’s air pathway circuit which extends from the device outlet, humidifier, tubing and mask and be inhaled or swallowed by the patient.
- Release certain toxic chemicals into the device’s air pathway, which may be inhaled by the patient.
PE-PUR foam degradation can result in serious injury, which can be life-threatening, including cancer and respiratory conditions. The potential health risks from exposure to particulate debris or toxic chemicals released into the device’s air pathway from the PE-PUR foam can include:
- Lung cancer or damage
- Kidney cancer or failure
- Liver cancer or failure
- Colon cancer
- Heart attack or heart failure
- Stroke
- Chronic obstructive pulmonary disease (COPD)
- Respiratory distress or failure
- Hypoxia (a lack of oxygen)
- New or worsening asthma
- Hypersensitivity
- Irritation to the skin, eye, or respiratory tract
- Headache
- Nausea and vomiting
- Dizziness
The foam degradation may be exacerbated by high heat and humidity environments, and by use of unapproved cleaning methods, such as ozone.
Who May Be Affected by the Recall
CPAP, BiPAP and ventilator devices are used to provide breathing assistance to patients with sleep apnea and other medical conditions. These machines differ slightly in their intended use.
- A bilevel positive airway pressure (also known as BiPAP, BiLevel PAP, or BPAP) machine pumps air under pressure into the airway of the lungs. BiPAP machines have a higher pressure when you breathe in and lower pressure when you breathe out.
- A continuous positive airway pressure (also known as CPAP) machine keeps your airway open by providing a continuous stream of air through a mask. CPAP machines are devices prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
- A continuous ventilator device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
CPAP, BiPAP and Ventilator Litigation
A growing number of defective CPAP, BiPAP and ventilator lawsuits have been filed against Philips Respironics in courts around the U.S. Plaintiffs allege that the affected ventilation machines are defectively designed as they use PE-PUR foam for sound and vibration attenuation which is known to degrade and release particulate debris and toxic chemicals into the device’s air pathway which can be inhaled by the patient.
The lawsuits also claim that Philips Respironics knew or should have known that PE-PUR foam is prone to breaking down and that the ventilation machines exposed patients to the risk of serious and permanent injuries and that the company failed to adequately warn U.S. physicians and patients about these serious side effects. Plaintiffs further claim that Philips Respironics did not adequately test their ventilation machines before putting them on the market.
Maine CPAP, BiPAP and Ventilator Lawsuit & Settlement Lawyer
If you or a loved one has used a Philips Respironics CPAP, BiPAP or ventilator, you may be entitled to significant compensation for any injuries you have suffered, including reimbursement of medical expenses, lost wages, pain and suffering, disability and permanent injury, punitive damages, and wrongful death.
To speak with an experienced Maine CPAP, BiPAP and ventilator lawyer, contact Fitzgerald Law Group at (844) FITZ-LAW or complete the contact form on this website for a free, confidential, case assessment.
