Philips CPAP Recall - VHA National Center for Patient Safety
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Philips CPAP Recall

Philips CPAP and BiLevel PAP Recall

Philips Respironics announced a voluntary recall for certain CPAP, BiLevel PAP, and mechanical Ventilator Devices due to issues related to deterioration of the sound abatement foam used in these devices. This recall affects CPAP and BiLevel PAP devices manufactured prior to April 26, 2021. VA has distributed approximately 300,000 of these devices to Veterans for home use. An additional 2,000 devices are used within VA in hospital or clinic settings.

DreamStation)

DreamStation

SystemOne

SystemOne


VA clinical teams are reviewing patient records to identify those who have received these devices and will work directly with impacted Veterans to repair or replace their equipment.

While there is a potential risk from the deterioration of the sound abatement foam, those risks have to be balanced against the known health risks of untreated sleep apnea. VA clinical experts are working with the FDA and the manufacturer to understand those risks. We expect to issue additional guidance in the coming days.

Veterans with questions can send a secure message to their care team through MyHealtheVet.


Frequently Asked Questions

Why are the Philips Respironics CPAP and BiPAP devices being recalled?

The manufacturer has identified a problem with a breakdown of the foam material used for sound reduction in their CPAP and BiPAP devices. Very small particles from the foam could break lose and come through the air hose.

What should Veterans do if they have use Philips Respironics CPAP or BiPAP device?

If you use a Philips Respironics CPAP or BiPAP device, continue to use your device as prescribed. You should register your device at https://www.philipssrcupdate.expertinquiry.com. Philips Respironics will send you a new device when one is available. This may take up to a year. If you are concerned about using your current device, call your care team or send them a secure message through MyHealtheVet to schedule an appointment.

What are the health risks if I continue to use my device?

The potential risks of degraded foam exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects. To date, Philips Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. No serious adverse health events have been reported.

What devices are more likely to have a problem with the foam?

Philips guidance shows that the likelihood of foam breakdown is higher in devices that are more than three years old, are used in high heat and humidity environments (more than 95 degrees) or that were cleaned with an ozone sterilizing device.

What causes the foam to break down?

Philips Respironics testing indicates that the breakdown is primarily caused by the devices being used in high heat and high humidity environments or using unapproved cleaning methods such as ozone. Most of the devices found with this issue have been in use for more than three years and have been routinely cleaned with an ozone cleaner.

If I stop using my CPAP or BiPAP device will my disability benefits be impacted?

No. If you and your care team decide to pause the use of your CPAP or BiPAP your disability benefits will not be impacted.

If these devices are being recalled, why should I still use mine?

While there is a potential risk from the deterioration of the sound reduction foam, those risks have to be balanced against the known health risks of untreated sleep apnea. VA clinical experts are working with the FDA and the manufacturer to understand those risks. We expect to issue additional guidance in the coming days.

Will my CPAP or BiPAP be replaced?

Each patient's needs are different, and your care team will determine if a CPAP or BiPAP from a different manufacturer will work for you, if a replacement is available, or if PAP therapy is no longer recommended for you. It is VA's goal for Veterans who continue with PAP therapy to be provided with a replacement device as soon as possible. VA requests that you register your device through the Philips Respironics Patient Portal at: https://www.philipssrcupdate.expertinquiry.com or call 877-907-7508. Philips Respironics will send you a replacement device. This may take up to a year.

Does this recall impact VHA sleep clinics?

Due to the volume of units affected, VHA sleep clinics may need to alter day-to-day operations as they support Veterans impacted by the recall.

When I registered on Philips site, they asked if I used an ozone sanitizer. Is that because I voided the warranty by using the cleaning device?

Response from Philips Respironics: "Our testing has shown that the use of ozone cleaners can accelerate the breakdown of the foam. The more we know about these devices the more research we can do. It has no bearing on the warranty."

How should I clean my CPAP or BiPAP device?

Only clean your device according to the manufacturer's recommendations. Using ozone or ultraviolet light cleaners may contribute to breakdown of the sound reduction foam.

Does this issue only impact devices purchased by VA?

No. This impacts all Philips Respironics CPAP and BiLevel PAP devices sold worldwide prior to April 26, 2021.

Is additional information available on the Philips Respironics device recall?

More information is available at http://www.philips.com/src-update.