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The Potential Health Risks Poised by Recalled Ventilators

By Snyder Sarno D'Aniello Maceri & da Costa LLC on August 30, 2021


Philips Respironics and the Health Risks Poised by Recalled Ventilators

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 health care 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 health care 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 ASV

Dream Station ST, AVAPS

System One ASV4

C-Series ASV

C-Series S/T and AVAPS

      Omni Lab Advanced+

Noncontinuous Ventilator

System One  (Q-Series)

Dream Station

Dream Station Go

Dorma 400

Dorma 500

      REMstar SE Auto

 

Ventilators:

Device Type: Model Name and Number:
      Continuous Ventilator

Trilogy 100

Trilogy 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 A40

A-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 Snyder Sarno D’Aniello Maceri & da Costa LLC today. You can schedule a consultation via email (pdacosta@snydersarno.com) or call us at (973) 274-5200.

 

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