Philips CPAP and BiPAP Device

What are philips cpap and bipap devices?

Philips CPAP (Continuous Positive Airway Pressure) and BiPAP (Bilevel Positive Airway Pressure) devices are innovative medical tools designed to provide crucial support for individuals suffering from sleep apnea and other related respiratory conditions. These devices play a vital role in ensuring that users maintain an unobstructed airflow throughout the night, leading to a more restful and healthier sleep pattern. Here’s a detailed look at their uses:

Philips CPAP Devices

The Philips CPAP devices are engineered to deliver a steady stream of air through a mask and tubing system, creating a gentle pressure in the airways that keeps them open while the user sleeps. This continuous airflow prevents the pauses in breathing that are characteristic of sleep apnea, significantly reducing the risk of sudden awakenings and ensuring a deeper, more consistent sleep cycle. Ideal for those with obstructive sleep apnea, Philips CPAP devices are celebrated for their ability to improve sleep quality, enhance daytime alertness, and lower blood pressure in users.

Philips BiPAP Devices

While CPAP devices provide a constant level of air pressure, Philips BiPAP devices offer a more sophisticated approach, delivering two distinct levels of air pressure: one for inhalation (IPAP) and a lower one for exhalation (EPAP). This dual-pressure technology makes breathing more natural and comfortable for users, especially those who have difficulty tolerating the constant pressure from CPAP machines or those with more complex forms of sleep apnea. BiPAP devices are also beneficial for individuals with certain types of respiratory failure, providing critical support that can significantly improve breathing patterns and overall health.

philips cpap and bipap recalls

On June 30, 2021, the FDA alerted the public that Philips recalled certain devices due to concerns regarding its polyester-based polyurethane sound abatement foam. ⁽¹²⁾ The FDA has recognized this as a Class I recall, “the most serious type of recall. Use of these devices may cause serious injuries or death.” ⁽¹³⁾

“The off-gassed chemicals and foam particles may lead to serious or life-threatening injuries, difficulty breathing (respiratory distress), swelling (inflammation), a lack of oxygen (hypoxia), too much carbon dioxide (hypercarbia), or toxic reactions.” ⁽¹⁴⁾

There have been 83 complaints reported as of July 22, 2021. All serial numbers of these types of devices and models have been recalled: ^{(15) (16)}

Recalled CPAP and BiPAP Devices

Continuous ventilator, minimum ventilatory support, facility use – E30.

Continuous ventilator, non-life supporting – DreamStation ASV; DreamStation ST, AVAPS; SystemOne ASV4; C-Series ASV; C-Series S/T and AVAPS; OmniLab Advanced+.

Noncontinuous ventilator – SystemOne (Q-Series); DreamStation; DreamStation Go; Dorma 400; Dorma 500; REMstar SE Auto.

Recalled Ventilators

Continuous ventilator – Trilogy 100; Trilogy 200; Garbin Plus, Aeris, LifeVent.

Continuous ventilator, minimum ventilatory support, facility use – A-Series BiPAP Hybrid A30 (not marketed in U.S.); A-Series BiPAP V30 Auto.

Continuous ventilator, non-life supporting – A-Series BiPAP A40; A-Series BiPAP A30.

The Dangers of Foam inhalation from philips bipap and cpap devices

According to the U.S. Food & Drug Administration (FDA), “The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.” ⁽⁵⁾

On November 12, 2021, the FDA provided an update on the recall. The FDA had inspected a Philips facility “to determine what may have caused or contributed to the foam issues and to assess adherence to the agency’s quality system regulations.” ⁽⁶⁾

During the inspection, the FDA learned that Philips’ replacement foam, which is silicone-based, may contain volatile organic compounds (VOCs). The FDA requested an independent laboratory test the foam for any potential safety risks.

Additionally, the FDA inspection revealed that Philips was aware no later than 2015 that the polyester-based polyurethane foam (PE-PUR) foam that is the subject of the recall had a degradation issue that was dangerous to users. Internal company testing also revealed the toxicity and potential carcinogenicity of the PE-PUR foam degradation products, yet Philips chose to keep using the PE-PUR foam over safer alternatives.

Philips Respironics, the manufacturer, used PE-PUR foam to lessen the sound and vibration of its breathing devices. However, if this foam comes into contact with your airways or digestive tract, dangerous side effects or medical complications may occur: 

If the foam breaks down, you may inhale or swallow foam particles.
Foam particles may release toxic chemicals, which you can breathe in or ingest.

Inhaling or swallowing PE-PUR foam particles can lead to serious injury. Possible injuries can be life-threatening. Injuries may also be permanent. Medical treatment may be necessary to prevent irreversible damage.

Complaints and dangerous side effects of Philips CPAP and Bipap devices

Philips has received complaints from patients who have noted black debris, or particles, in their breathing device’s air pathway. Patients have reported headaches, irritation in their upper airway, chest pressure, a cough, and sinus infections. These side effects may be linked to inhalation of foam particles.

Long-term, permanent, and life-threatening health complications – including cancer – of PE-PUR foam are possible. If you are diagnosed with any of these conditions, your illness may be linked to your use of Philips CPAP and BiPAP:

• Acute Respiratory Distress Syndrome (ARDS)
• Reactive Airway Disease
• Respiratory failure
• Recurrent pneumonia
• Pleural effusion
• Lung/Pulmonary disease
• Lung/Pulmonary damage
• Severe ear, nose, and throat inflammation
• Liver damage
• Liver disease
• Kidney/Renal damage
• Kidney/Renal disease
• Chemical poisoning

Legal options after experiencing injury from a philips bipap or cpap device

If you or a loved one suffered serious medical complications or a health injury after using a recalled Philips medical device, you may be entitled to compensation. Compensation may cover medical expenses, as well as your pain and suffering, loss of earnings, and potential future income loss. Punitive damages may also be awarded.

Possible compensation you could receive includes:

• Costs due to doctor visits.
• Medication reimbursement.
• Nursing and other related care costs
• Money for days you were not able to work due to your injury.
• Money for future income you cannot make if your injury does not allow you to work.

Time is limited. If you are ready to file a claim for your medical complications or injury due to a recalled Philips medical device, call Shunnarah now.