On June 14, 2021, Philips Respironics voluntarily recalled certain ventilation and sleep apnea devices due to potential health risks.[1] According to the U.S. Food and 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.[2]
These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage. The potential risks include, but are not limited to irritation to the skin, eye, and respiratory tract, inflammatory response, headache, dizziness, nausea/ vomiting, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.
The FDA released a statement on June 30, 2021, urging patients who use the following BiPap or CPAP machines to discontinue the use of the product and to consult with their healthcare providers to decide on a suitable treatment. (See chart below). In addition, the FDA advises patients who use the following ventilators to not discontinue the use of the device without consulting their healthcare provider. (See chart below).[3]
BiPap/ CPAP Devices:
| Device Type: | Model Name and Number: |
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use | E30 |
| Continuous Ventilator, Non-life Supporting | Dream Station ASVDream Station ST, AVAPSSystem One ASV4C-Series ASVC-Series S/T and AVAPS Omni Lab Advanced+ |
| Noncontinuous Ventilator | System One (Q-Series)Dream StationDream Station GoDorma 400Dorma 500 REMstar SE Auto |
Ventilators:
| Device Type: | Model Name and Number: |
| Continuous Ventilator | Trilogy 100Trilogy 200 Garbin Plus, Aeris, Life Vent |
| Continuous Ventilator, Minimum Ventilatory Support, Facility Use | A-Series BiPAP Hybrid A30 (not marketed in the US)A-Series BiPAP V30 Auto |
| Continuous Ventilator, Non-life Supporting | A-Series BiPAP A40A-Series BiPAP A30 |
Philips Respironics has received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics also has received reports of headache, upper airway irritation, cough, chest pressure, and sinus infection, which may be related to this issue. If you feel that you or a loved one may have been affected by any of the above devices please contact Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLC today. You can schedule a consultation via email (pdacosta@sarnolawfirm.com) or call us at 973-274-5200.
[1] Philips Recall: https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
[2] United States Federal Food and Drug Administration: https://www.fda.gov/medical-devices/safety-communications/philips-respironics-cpap-bipap-and-ventilator-recall-frequently-asked-questions
[3] United States Federal Food and Drug Administration: https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks#actions
