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June 2021 Philips Respironics CPAP/BIPAP/Mechanical Ventilator Recall

On June 14, 2021, Philips Respironics (Philips) announced a voluntary recall for certain BiLevel Positive Airway Pressure (BIPAP), Continuous Positive Airway Pressure (CPAP), and ventilator devices due to potential health risks related to deterioration of the sound abatement foam used in these devices. This recall is for all CPAP and BIPAP devices manufactured by Philips prior to April 26, 2021. 

Philips advises patients using the recalled BIPAP and CPAP devices to discuss with their health care provider(s) the risks and benefits of continued use to determine appropriate next steps. Providers should encourage patients to register their device through the Philips patient portal at www.philipsrcupdate.expertinquiry.com, or call 1-877-907-7508 to see if the particular device is part of the recall.

Key Resources 

Frequently Asked Questions 

Why are certain Philips BIPAP, CPAP and mechanical ventilator devices being recalled?
The manufacturer has identified a problem due to a breakdown of the foam used to reduce sound and vibration in these devices. Very small particles or dust from the foam could break loose and come through the air hose. There was also a concern for exposure via off-gassing (detecting the scent of chemicals that are released in vapor form while the device is in use). 
 

How do patients find out if their devices are part of the Philips recall?
Patients can find out if a device is part of the recall by visiting the Philips website. Patients, users and caregivers can look up the device serial number and begin a claim if their unit is affected at www.philipssrcupdate.expertinquiry.com or by calling 1-877-907-7508.
 

Should patients keep using their devices if they are part of the Philips recall?

  • If a patient is using an affected BIPAP and CPAP device: Consider the risks and benefits of continued use of the CPAP versus discontinuing use as the Philips recall advises. If a patient struggles with daytime sleepiness, impaired concentration, sleepiness while driving, or poor quality of life when not using the CPAP, advise the patient to continue to use the current device until an option for a comparable replacement or repair is available. In the risk versus benefit analysis of continued CPAP use, factor into the equation the patient’s job and need for a good night’s sleep, such as those on flight status, those who operate hazardous equipment or firearms, or those in the medical field.
     
  • If a patient is using an affected life-sustaining mechanical ventilator device: Do not stop or alter the prescribed therapy. The benefit of continued usage of these ventilator devices may outweigh the risks identified in the recall notification.


What cleaning products or devices should patients use/avoid?
Since each type and brand of CPAP machine is different, patients should follow the cleaning schedule and instructions from the company that made the CPAP machine. Refer to the device’s owner’s manual for approved cleaning methods. Most CPAPs can be cleaned with mild soap and water as described in the owner’s manual for the machine. Some manufacturers recommend using diluted vinegar. Find additional information on cleaning at https://www.fda.gov/consumers/consumer-updates/cpap-machine-cleaning-ozone-uv-light-products-are-not-fda-approved.

Commercial CPAP cleaning devices that use ozone or ultra-violet light to clean, sanitize or disinfect CPAP devices are a concern as well. The FDA previously published a safety communication to patients about them not being legally marketed for this use by the FDA in the United States; safety risks are unknown. See https://www.fda.gov/news-events/press-announcements/fda-reminds-patients-devices-claiming-clean-disinfect-or-sanitize-cpap-machines-using-ozone-gas-or.
 

Will the patient’s Philips device be replaced or repaired?
Encourage patients to register their device through the Philips website or call 1-877-907-7508 to see if the particular device is part of the recall and to begin a claim if the unit is affected. Philips will provide the patient with information for repairing or replacing the device if affected by the recall. Most likely, current models of devices will be replaced and repairs would be targeted to older model devices that are no longer manufactured.


How long will it take to get a replacement or get the device repaired? What should be done in the interim?
It will likely be some time before replacement machines are available from Philips. Please refer to the Philips website and/or call 1-877-907-7508 for more information. 


Will TRICARE pay for a new, non-recalled device?
As per the TRICARE Policy Manual, TRICARE will cover a new, non-recalled device when a medically-necessary device has been recalled. Patients using their TRICARE benefit will need a new prescription/Certificate of Medical Necessity (CMN) from their provider (or referral for durable medical equipment) to receive a new device. Patients may need to pay appropriate copays or cost-shares based upon their TRICARE plan. Due to the recall and national demand, new devices may not be readily available.
 

Is an HNFS approval required for beneficiaries who are replacing recalled devices?
TRICARE West Region beneficiaries who go through Phillips for repair or replacement do not need HNFS approval. However, for beneficiaries who choose to use their TRICARE benefit (and not go through Phillips), HNFS will need a new authorization request per TRICARE guidelines. Please indicate on the request it is for a recalled device. 
 

Will TRICARE accept claims for replacement equipment for recalled devices less than five years old?
Yes. TRICARE will reimburse for recalled devices even if the patient has had the device for less than five years. 
 

What impact will this recall have on a patient scheduled for a sleep study?
Due to the volume of units affected, sleep centers may have to reschedule sleep study appointments until replacement devices are purchased or current equipment is repaired. Diagnostic sleep studies such as home sleep testing and in-laboratory polysomnography are not affected by the recall. Laboratories that use Philips devices affected by the recall for CPAP and BIPAP titrations may be impacted. Patients should talk to their physician about balancing the risks of using a PAP device for one night in the laboratory to optimize diagnosis and treatment settings against exposure risks that are likely minimal (i.e., exposure to a recalled device for several hours during a sleep study).
 

Where are the latest updates regarding the Philips device recall?
More information is available at www.philips.com/src-update, or contact Philips at 1-877-907-7508.

 

 

Source: U.S. Department of Defense Patient Safety Program July 2021, Patient Safety Advisory