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Philips C-PAP and Other Ventilator Machines Recalled Due To Toxic Foam

  • Written by: Russell Maas
  • 4 Comments

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The medical device manufacturer Philips has issued a recall that impacts millions of sleep-apnea devices and mechanical ventilators, which contain sound abatement foam that may degrade over time and release toxic gases, potentially exposing users to a risk of cancer.

The Philips Bi-PAP, C-PAP and ventilator recall was announced by the manufacturer on June 14, after identifying a potential health risk associated with the device’s polyester-based polyurethane (PE-PUR) sound abatement foam, which the company warns can degrade and release particulate matter into patients’ airways.

Approximately 3.5 million Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices were equipped with PE-PUR sound abatement foam, which are being withdrawn from the market due to evolving health concerns.

Philips announced this week that internal testing revealed the PE-PUR sound abatement foam has the potential to “degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and the foam may off-gas certain chemicals.” Philips indicated the particulate matter and gases may be toxic to patients and could potentially cause cancer.

To date, Philips has received several complaints of the devices causing patients headache, irritation, inflammation and respiratory issues after inhaling the polyester-based polyurethane foam, representing approximately 0.03 percent of devices sold in 2020.

An investigation by the manufacturer determined unapproved cleaning methods of the devices such as ozone and high heat and high humidity environments may be a contributing factor to the accelerated deteriorating of the PE-PUR sound abatement foam. However, an investigation is still ongoing.

Owners of the Philips C-PAP and Bi-Level PAP machines, representing about 80% of the devices recalled, have been instructed to stop using the devices immediately, and to consult with their healthcare professional for an alternative.

The remaining 20% of the recalled devices are mechanical ventilators. Philips recommended doctors and patients using life-sustaining ventilators should first consider whether the potential danger from the foam outweighs other risks.

The recall notice claims the company is working closely with regulatory agencies to provide customers a resolution which will include the deployment of updated instructions for use and a comprehensive repair and replacement program for the affected devices.

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4 comments

  1. John Reply

    Philips says stop using immediately yet they give no replacement immediately. Due to help conditions Dr recomends continue usage.

  2. James Reply

    I was diagnosed with esophageal cancer December 2020. I have had radiation and chemo treatments as well as surgery to remove tumour on March 31, 2021. Now I have to have further 4 chemo treatments at a higher dose. It was recommended that I use Cpap machine as I wasn’t breathing properly and had a heart attack. I was shocked to hear the info when going to Cpap supplier to replace filter.

  3. Daryl Reply

    I had mine since 2017, I have had soar throat, I was constantly taking it off because it would make me toss and turn. It has affected my sleep where at times I would not get the proper sleep for a couple days.. one time three days! I have no idea if the leak is possibly part of the problem. I currently seeking sleep phycologist at Penn sleep medicine, as well as taking Modifinil to help me function during the day.

  4. Chris Reply

    @James, my father was also diagnosed with esophageal cancer. He never smoke or drank but used a recalled CPAP and was regularly cleaned with an ozone machine. Were you using the device prior to your diagnosis or only after?

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