Philips CPAP, BiPAP and Ventilator Recall

If you have used the recalled Philips CPAP, BiPAP, or ventilator machines and have been diagnosed with lung cancer or other serious or life-threatening injuries, you may have a claim for for money damages. Please call Attorney Marilyn McGoldrick at 1-877-948-2727 (or 1-877-948-CPAP), or tell us your story online.

UPDATE: The U.S. Food and Drug Administration on July 22, 2021 classified the recall of Philips Respironics CPAP and BiPAP breathing devices and ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death.

What Can You Do?

If you were using one of the recalled Philips CPAP, BiPAP, or ventilator machines, please consult your doctor for advice on how to proceed. If you use one of the recalled machines and have experienced airway irritation or inflammation; breathing difficulty; lung damage; new or worsening asthma, pneumonia, lung cancer, kidney, liver, or colon cancer; a heart attack or heart failure; stroke; respiratory failure, liver disease; or kidney disease, you may have a claim for damages against the manufacturer. Contact the Boston law firm of Thornton Law Firm LLP online or call Attorney Marilyn McGoldrick at 877-948-2727 (or 877-948-CPAP) for a free consultation with a recognized leader in Massachusetts drug and medical device litigation. You have nothing to risk. We offer a fair and accurate assessment of your case. The consult is free and will be held in strictest confidence.

On June 14, 2021, Philips Respironics issued an urgent recall of many of their CPAP, BIPAP and ventilator devices. The polyester-based polyurethane (PE-PUR) sound-insulating foam used inside the machines may degrade over time. The degraded particles and chemicals in that foam then can make their way into the airway portion of the devices. Inhaling, ingesting, or absorbing these toxins can increase your risk of lung cancer and other serious or life-threatening injuries.

FDA Recommendations for People Who Use Affected BiPAP or CPAP Machines

The FDA indicates people who use Philips DreamStation, CPAP or BiPAP machines should consult their physicians immediately and seek a suitable treatment alternative. The treatment alternatives outlined by the FDA are:

  • Stopping use of your device
  • Using another similar device that is not part of the recall
  • Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
  • Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.
  • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.

Unfortunately, because the recall covers almost 4 million machines, there is likely to be limited availability for other breathing machines, and alternative treatments for sleep apnea or lifestyle changes may not be possible in the short term.

FDA Recommendations for People Who Use Affect Ventilators

The FDA recommends ventilator users not to stop or change ventilator use until consulting their physician. Use of an inline bacterial filter may help ventilator users filter out particles of foam. However, this filter is untested and will not affect exposure to off-gassed chemicals. In addition, filters may affect ventilator performance and resistance of air flow. Closely monitor for possible accumulation of foam debris on the filter or resistance-related problems.

What Injuries Can the Recalled CPAP, BiPAP and Ventilator Machines Cause?

Philips’ recall notice advised that the polyester-based polyurethane foam in these devices degrades and/or off-gasses, posing risks of serious injuries to users, including:

  • Airway irritation (skin, eyes, nose, respiratory tract)
  • Inflammatory response (airway inflammation)
  • Breathing difficulty
  • Lung Damage
  • Asthma (new or worsening)
  • Pneumonia
  • Toxic carcinogenic effects (Lung, kidney, liver colon cancers)
  • Heart attack/heart failure
  • Stroke
  • Respiratory failure
  • Liver disease
  • Kidney disease

What CPAP machines have been recalled?

The Philips CPAP recall list includes these models manufactured before April 26, 2021:

CPAP & BiPAP Devices:

  • E30 Ventilator (under emergency use authorization)
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go
  • Dorma 400
  • Dorma 500
  • REMstar SE Auto

Mechanical Ventilator Devices:

  • Trilogy 100
  • Trilogy 200
  • Garbin Plus, Aeris, LifeVent
  • A-Series BiPAP Hybrid A30 (not marketed in US)
  • A-Series BiPAP V30 Auto
  • A-Series BiPAP A40
  • A-Series BiPAP A30

Reporting Problems With Your Device

If you think you had a problem with a CPAP, BiPAP, or mechanical ventilator, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.

 

 

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