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Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

 

September 10, 2021 Update : The FDA has taken additional actions related to the Philips Respironics ventilators, BiPAP, and CPAP recall. For details, see FDA Actions below.

Date Issued: June 30, 2021

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 (see table below) due to potential health risks. 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.

If you use one of these affected devices (see table below), talk to your health care provider to decide on a suitable treatment for your condition and follow the recommendations listed below.

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

BiPap or CPAP: Recommendations for People Who Use Affected BiPAP or CPAP Machines and Caregivers

  • Talk to your health care provider to decide on a suitable treatment for your condition, which may include:
    • Stopping use of your device
    • Using another similar device that is not part of the recall
    • Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
    • 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.
  • Follow the manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. Ozone cleaners may worsen the breakdown of the foam, and there are other potential risks associated with the use of ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories.
  • Register your device(s) on Philips Respironics’ recall website to stay informed of updates from Philips Respironics regarding any new instructions or other corrective fixes, which the FDA is requiring.
  • Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

Ventilators: Recommendations for People Who Use Affected Ventilators At Home and Caregivers

  • Do not stop or change ventilator use until you have talked to your 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. 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.
    • You should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.
  • Register your device(s) on Philips Respironics’ recall website.
  • Report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

Recommendations for Health Care Providers and Facilities

  • Follow the recommendations above for the affected devices used in health care settings.
  • Review the recommendations above with patients who use the affected devices.
  • Service affected devices and evaluate for any evidence of foam degradation.
    • If there is evidence of foam degradation, such as black debris in the device, stop use of the device, if possible, and report any problems with a device through the FDA’s MedWatch Voluntary Reporting Form.

Description of the Devices

These devices are used to provide breathing assistance. Specifically:

  • A bilevel positive airway pressure (also known as BiPAP, BiLevel 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
  • 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.

To date, there have been no reports of death as a result of these issues.

FDA Actions

The FDA has initiated on-site inspections of Philips Respironics’ manufacturing facilities to assess compliance with regulatory requirements. 

In addition, on September 10, 2021, the FDA updated the frequently asked questions about this recall on FDA.gov: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions

The FDA reviewed and concurred with Philips’ Respironics plan for recalled DreamStation CPAP and BiPAP machines, specifically DreamStation CPAP; Pro, Auto (All Configurations), Dream Station BiPAP; Pro, Auto (All Configurations) and DreamStation ST, ASV, AVAPS (All Configurations). Philips Respironics announced on September 1, 2021, “Philips anticipates rework to commence in the course of September 2021. In addition to the rework, the company has already started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices” and “intends to complete the repair and replacement programs within approximately 12 months.” Philips Respironics’ implementation of a plan to fix the problems with the Philips Respironics products is a high priority for the FDA.

The FDA is committed to using every tool at our disposal to increase the availability of these medical products. The FDA is working with Philips Respironics to monitor the repair or replacement of impacted devices as expeditiously as possible and is continuing to gather information to inform our actions. We are collaborating with other manufacturers and government partners to support availability of CPAP and BiPAP machines.

Philips Respironics has not yet provided the FDA with all the information needed for the FDA to evaluate the plan to repair and replace products across all the Philips Respironics’ recalled devices, including the Trilogy ventilators, A-series BiPAP machines, C-series BiPAP machines, OmniLab Advanced+, Garbin Plus, Aeris, LifeVen, E30 ventilator, REMstar SE Auto, and E30.

In July, the FDA identified this device problem as a Class I recall, the most serious type of recall and posted frequently asked questions.

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

The FDA 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 does not have evidence at this time that any other CPAP machines, BiPAP machines, or ventilators, from Philips or other manufacturers, are affected.

In addition, the FDA added product codes MNS and MNT to the device shortage list due to device availability issues. These product codes, which also include other types of ventilation-related products, are related to continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines. With the addition of these product codes, the device shortage list contains all the product codes under which CPAP and BiPaP machines are classified. These product codes can be found under the category Ventilators – Ventilation-Related Products category on the device shortage list. 

The FDA will continue to share updates with the public as more information becomes available.

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.

Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

Questions?

The FDA posted answers to frequently asked questions about this recall:  Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions

For more information on the recall notification, contact your local Philips representative or visit Philips Respironics’ recall notification web page.

More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.

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