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FDA announces CPAP Recall, More

Philips Respironics Ventilators, BiPAP, CPAP Machines recalled due to potential health risks

On June 30, 2021, The U.S. Food and Drug Administration (FDA) announced it was alerting health care providers and people who use Philips Respironics ventilators, BiPAP, and CPAP machines that Philips Respironics has recalled certain devices (see below) due to potential health risks. The FDA said in a safety communication that polyester-based polyurethane (PE-PUR) sound abatement foam 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.”

The agency said that those who use one of the affected devices should speak with a health care provider to decide on a suitable treatment for their condition and follow the recommendations the agency lists.

Philips Respironics is recalling the following affected devices manufactured between 2009 and April 26, 2021. For details, see Philips’ Respironics recall notification  (PDF).

CPAP and BiPAP Devices

Device Type Model Name and Number (All Serial Numbers)
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
Continuous Ventilator, Non-life Supporting
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
Noncontinuous Ventilator
  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go
  • Dorma 400
  • Dorma 500
  • REMstar SE Auto

Ventilators

Device Type Model Name and Number (All Serial Numbers)
Continuous Ventilator
  • Trilogy 100
  • Trilogy 200
  • Garbin Plus, Aeris, LifeVent
Continuous Ventilator, Minimum Ventilatory Support, Facility Use
  • A-Series BiPAP Hybrid A30 (not marketed in US)
  • A-Series BiPAP V30 Auto
Continuous Ventilator, Non-life Supporting
  • A-Series BiPAP A40
  • A-Series BiPAP A30

Recommendations for Caregivers and Users affected by BiPAP or CPAP Machines

  • FDA recommends talking to your health care provider to decide on a suitable treatment for your condition. Steps may include but not be limited to:
  • Stopping use of your device
  • Using another similar device which is not part of the recall
  • Using alternative treatments for sleep apnea, such as positional therapy or oral appliances that fit like a sports mouth guard or an
  • Using alternative treatments for sleep apnea, such as positional therapy or oral appliances that fit like a sports mouth guard or an orthodontic retainer.
  • Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, ceasing smoking, or even considering surgical options.
  • Continuing to use your affected device, if your health care provider determines  the benefits outweigh risks identified in the recall notification.

FDA further recommends that those concerned:

FDA Recommendations for Caregivers and At-Home Users of Affected Ventilators

FDA cautions ventilator users not to stop or change ventilator use until speaking with a health care provider.

  • Alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and in the judgment of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification.
  • Talk to your health care provider about using an inline bacterial filter, which may help to filter out particles of foam, as indicated in the Philips recall notification. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and the FDA’s evaluation is ongoing.

FDA also announces it is important to note the following considerations:

  • Filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.
  • Filters may affect ventilator performance because they may increase resistance of air flow through the device.
  • Users should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.

Description of the Philips’ Devices

These devices are used to provide breathing assistance. Specifically:

  • A bilevel positive airway pressure (also known as BiPAPBiLevel PAP, or BPAP) machine pumps air under pressure into the airway of the lungs. BiPAP machines have a higher pressure when you breathe in and lower pressure when you breathe out.
  • A continuous positive airway pressure (CPAP) machine keeps your airway open by providing a continuous stream of air through a mask. CPAP machines are devices prescribed to people with obstructive sleep apnea to keep their airways open during sleep.
  • A continuous ventilator device is intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.

PE-PUR Foam May Be Inhaled or Swallowed, Presenting a Potential Health Risk

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, and release certain chemicals into the device’s air pathway, which may be inhaled. These issues can result in serious, even life-threatening injury; cause permanent impairment; require medical intervention to prevent permanent damage.

Complaints over Debris to Philips Respironics

Philips Respironics has, to date, received several complaints about the presence of black debris/particles within the device’s air pathway. Philips Respironics has also 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.

Potential Risks, Injuries

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, skin
  • hypersensitivity
  • nausea/vomiting
  • toxic and carcinogenic effects.

The foam degradation may be worsened by high heat and high humidity environments, and by the use of unapproved cleaning methods such as ozone. To date, there have been no death has been reported as a result of these issues.

FDA Actions

The FDA is working with Philips Respironics to evaluate the issue, the scope of the recall, and the most appropriate mitigation strategies, including corrective actions by Philips.

The FDA says it is analyzing medical device reports (MDRs) related to the affected devices over the period of 2009-2021 for reports that could be related to this issue.

The FDA also says it does not currently have evidence that any other CPAP machines, BiPAP machines, or ventilators – whether from Philips or other manufacturers — are affected.

The FDA further reports that it will continue to monitor supply and demand to assess availability of the affected devices and any potential shortages, and will update the public as it learns more.

Reporting Problems with Your Device

FDA encourages those who think they may have a problem with a CPAP, BiPAP, or mechanical ventilator, to report the problem through the  MedWatch Voluntary Reporting Form.

Questions re: Medical Device Recalls?

FDA notes that those who want more information regarding medical device recalls –including  What is a Medical Device Recall? —  can find more information at FDA.gov.

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