Philips Respironics and the FDA have issued a Class 1 recall on medical respirator devices used in the treatment of Sleep Apnea due to problems with the sound abatement foam. Class 1 recalls are the highest level of recall; use of these devices may cause serious injuries or death.
The polyester-based polyurethane (PE-PUR) foam is alleged to degrade into particles or gasses that are ingested or inhaled by the user. Potential risks can be life threatening, including adverse effects to the kidneys and liver, asthma, and toxic/carcinogenic effects.
Philips Recalls Breathing Devices
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.
There have been 83 complaints reported as of July 22, 2021. All serial numbers of these types of devices and models have been recalled:
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.
- 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.
Potential Life-Threatening Health Complications
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
Another serious concern is the possibility of developing different types of cancer. These cancers include:
- Multiple myeloma
- Oral, including palate and tonsils
- Papillary carcinoma
What Are Philips CPAP and BiPAP Devices Used For?
CPAP machines (continuous positive airway pressure) are the most commonly prescribed device for treating sleep apnea disorders. These devices send a steady flow of oxygen into your mouth and nose while you are sleeping, keeping airways open and helping you breathe.
A CPAP machine uses a compressor, or motor. This motor generates a steady stream of pressurized air, which then moves through an air filter and into a flexible tube. This tube allows purified air to move into a mask you wear. The mask is sealed around your nose and/or mouth as you sleep.
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