Philips Respironics URGENT: Medical Device Recall CPAP and Bi-Level PAP Devices
Sound Abatement Foam Susceptibility to Degradation and Volatile Organic Compound Emission
Philips Respironics has issued an urgent medical device recall of multiple CPAP and BiPAP ventilators. The action is the company’s response to 2 known issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in the devices. These issues can lead to serious, possibly life-threatening injury or permanent impairment.
The PE-PUR foam may degrade into dangerous particles which can enter the device’s air pathway and be ingested or inhaled by users. To date, Philips Respironics has received numerous complaints of black debris/particles in the airpath tubing, mask, humidifier, and device outlet.
Risks of Particulate Exposure Include
- Irritation (skin, eye, and respiratory tract)
- Inflammatory response
- Adverse effects to other organs (e.g., kidneys and liver)
- Toxic carcinogenic effects
PE-PUR foam has the potential to emit harmful gases called volatile organic compounds (VOCs). According to Philips Respironics these VOCs can include diethylene glycol, Toluene Diisocyanate, Toluene Diamine, Phenol Dimethyl Diazine. To date, Philips Respironics has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection.
Risks of Chemical Exposure Due to Off-gassing Include
- irritation (eyes, nose, respiratory tract, skin)
- Toxic carcinogenic effect