Philips CPAP Machine Recall LAWYER

What Are Assisted Breathing Devices and How Are They Used?

Three main categories of mechanical ventilation devices are typically used to treat sleep apnea and other breathing disorders:

A CPAP (continuous positive airway pressure) machine is most commonly used to treat sleep apnea. The device keeps the airway open by providing a continuous flow of oxygen into the nose and mouth through a mask connected to the machine via a tube. The device must be reset to change the air pressure level.

An APAP (automatic positive airflow pressure) machine automatically adjusts the air pressure level to compensate for changes in breathing due to sleep position or other factors.

A BiPAP (bilevel positive airway pressure) machine, also known as BiPAP or BiLevel PAP, has two different air pressure settings, a higher level for inhaling and a lower level for exhaling. BiPAP machines are often used for individuals with higher carbon dioxide levels or those who cannot use a CPAP machine.

Additionally, patients with severe respiratory distress may require a continuous ventilator, which takes over the breathing process by pumping a predetermined amount of oxygen into the lungs.

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Why Were the Philips Devices Recalled?

Specific safety concerns about the sound abatement foam used in numerous devices were first published on April 26, 2021 in Philips’ Quarterly Report. On June 14, 2021, Philips announced a voluntary recall of the affected devices. The FDA identified this as a Class I recall, the most serious kind, stating that “use of these devices may cause serious injuries or death.”

The recall notice states the polyester-based polyurethane (PE-PUR) foam used to make the devices quieter may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user. In addition, the foam may release, or “off-gas,” certain chemicals.

Further, the off-gassed chemicals and foam particles may lead to serious or life-threatening injuries such as difficulty breathing (respiratory distress), swelling (inflammation), lack of oxygen (hypoxia), excessive carbon dioxide (hypercarbia) or other toxic reactions.

According to Philips, the foam degradation may be exacerbated by high heat and high humidity environments as well as the use of unapproved cleaning methods such as ozone-based machines.

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Which Philips Assisted Breathing Products Have Been Recalled?

The majority of the affected devices are in the first-generation DreamStation product line.

As of September 10, 2021, the following Philips Respironics products have been recalled:

CPAP and BiPAP Devices

Continuous ventilator, minimum ventilatory support, facility use:
E30

Continuous ventilators, non-life supporting:
DreamStation ASV
DreamStation ST, AVAPS
SystemOne ASV4
C-Series ASV
C-Series S/T and AVAPS
OmniLab Advanced+

Noncontinuous ventilators:
SystemOne (Q-Series)
DreamStation
DreamStation Go
Dorma 400
Dorma 500
REMstar SE Auto

Ventilators

Continuous ventilators:
Trilogy 100
Trilogy 200
Garbin Plus, Aeris, LifeVent

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

Continuous ventilators, non-life supporting:
A-Series BiPAP A40
A-Series BiPAP A30

For new additions to this list and recent updates about the recall, visit the FDA website.

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