On June 30th, 2021, The U.S. Food and Drug Administration (FDA) alerted people that certain Ventilators, BiPAP, and CPAP machines were recalled due to potential health risks.
What is the reason for the recall?
A foam materia (Polyester-based polyurethane (PE-PUR)l that is used to reduce sound and vibration in the machine may break down and potentially enter the device’s air pathway.
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.
What Machines are affected?
The recall only pertains to Philips Respironics ventilators, BiPAPs, and CPAPs. However, only a select few of their Philips Respironics machines are affected. Here is a detailed table of the recalled machines:
- CPAPS
- DreamStation
- DreamStagion ST
- SystemOne
- C-Series
- C-Series S/T
- OmnilLab Advanced
- SytemOne (Q-Series)
- DreamStation Go
- Dorma 400
- Dorma 500
- REMstar SE Auto
- Ventilators
- Trilogy 100
- Trilogy 200
- Garbin Plus
- A-Series BiPAP Hybrid A30
- A-Series BiPAP V30 Auto
- A-Series BiPAP A40
- A-Series BIPAP A30
What To Do If You Are Affected?
CPAPS:
- Talk to your health care provider to decide on a suitable treatment for your conditions which may include:
- Stopping use of your device
- Start using a new device
- Continue the use your affected device, If your health care provider determines that the benefits outweigh the risks identified in the recall notification.
- Use an alternative treatment for sleep apnea.
- Follow the manufacturer's instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories.
- Register your device on the Philip’s Respironics’ recall website. https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
Ventilators:
- 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.
- Register your device on the Philip’s Respironics’ recall website. https://www.usa.philips.com/healthcare/e/sleep/communications/src-updateInsert link
Fresh Air Medical is here to help with the recent Respironics recall. We have discontinued the sale of all recalled machines and have issued replacement machines for all or any customers that have been affected. The CPAP machines we have for sale on our site are all 100% safe for consumer use. Please reach out to one of sale-representatives if you have any questions or are looking to purchase a new machine at 1-888-507-1621.
