Philips Respironics Recall Investigation

FDA Safety Communication Concerning Philips Respironics Recall

The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices due to potential health risks.

What Happened with these Devices

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.

Potential Health Risk from Inhaling or Swallowing PE-PUR Form

Polyester-based polyurethane (PE-PUR) is a sound abatement foam used to reduce sound and vibration in these devices and other medical equipment. The PE-PUR foam in the affected Philips Respironics CPAP, BiPAP, and ventilator devices may:

• Break down (degrade) into particles which may enter the device’s air pathway and be inhaled or swallowed by the user
• Release certain chemicals into the device’s air pathway, which may be inhaled

These issues can result in serious injury, which can be life-threatening, cause permanent impairment, and require medical intervention to prevent permanent damage.

To date, 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, though the cause of the symptoms cannot be definitively linked.

The potential risks of particulate exposure include irritation to the skin, eye, and respiratory tract, inflammatory response, headache, asthma, and toxic or carcinogenic effects to organs, such as kidneys and liver.

The potential risks of exposure to chemicals released into the device’s air pathway from the PE-PUR foam include headache; dizziness; irritation in the eyes, nose, respiratory tract, and skin; hypersensitivity; nausea/vomiting; and toxic and carcinogenic effects.

The foam degradation may be exacerbated by high heat and high humidity environments, and by use of unapproved cleaning methods, such as ozone.

Philips Respironics Recall Device List

CPAP and BiPAP Devices

Ventilators

What if I have a Device on the Philips Respironics Recall List

You should contact your healthcare provider immediately. If you have used a Philips Respironics Device for over six (6) months, you can use our case evaluator below to have an attorney review your potential case and discuss potential options.

Why Choose Davis & Norris for Your Philips Respironics Recall Claim

The National Law Review published “A Simple Guide to CPAP Lawsuits and Settlements.” When evaluating the need for an attorney to handle your CPAP lawsuit, it suggests a three step process:

• Step 1: Determine Whether Your Make and Model was Recalled

• Step 2: Look for a Related Injury

• Step 3: Contact a CPAP Attorney

For Step 1, you can review the list above. As to Step 2, the National Law Review points out, the science and the claims are in their early stages and it is not yet completely clear which types of injuries and illnesses can be definitively linked to the use of the recalled devices. However, as you would expect, you cannot expect to relate the first use of a recalled CPAP device to being diagnosed with an injury or illness the very next day. There is a latency period from when you first started using the recalled device, to when you first developed an injury. Once again, the science and claims are unsettled and different injuries and illnesses have different latency periods. Most forms of cancer will be reviewed by experts to determine a causal link. Other than cancer, an individual may have suffered severe lung or respiratory injuries (like pulmonary fibrosis) to inhalation of the PE-PUR particles.

The attorneys of Davis & Norris have expertise in handling a variety of exposure claims and are here to give you the dedicated attention your claim needs. Contact us today and we will answer any questions you may have about the Philips Respironics Recall.