Recall of Certain Philips PAP Devices

Philips Respironics has issued a recall for certain PAP devices including DreamStation PAP devices manufactured before April 26, 2021.  The newer DreamStation 2 is not affected.

The recall relates to the type of foam used to reduce the noise made by the devices. Over time, the foam inside the machine may degrade into particles. These particles can enter the humidifier, tubing and mask and patients may inhale the particles when using the device. Philips reports that the potential risks include headache, skin or eye irritation and asthma.  Philips also found that the foam can produce unsafe chemical levels. These “volatile organic compounds” are released as gases and may cause problems including irritation of the airway, headache or dizziness, skin, eye or nose irritation, and nausea or vomiting.

Philips text for patients

Patients can contact Philips using the underlined link below or by phone at (877) 907-7508

Patients can find more information about the recall here: Philips Recall Information.  This link allows patients to register and then look up their device to see if it is affected by the recall.  If their device is affected, the link allows patients to request assistance.  Patients can contact Philips Respironics directly through the link or by telephone at (877) 907-7508 for additional information and assistance with their PAP devices related to the recall.

Philips has issued this advice to patients:

For patients using life-sustaining mechanical ventilator devices:

  • Do not stop or alter your prescribed therapy until you have talked to your physician. Philips recognizes that 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 at the discretion of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the risks.
  • If your physician determines that you must continue using this device, use an inline bacterial filter. Consult your Instructions for Use for guidance on installation.
 For patients using BiLevel PAP and CPAP devices: 
  •  Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. 

The American Academy of Sleep Medicine has guidance for patients here: American Academy of Sleep Medicine Guidance for Patients.  There is additional information for clinicians here: American Academy of Sleep Medicine Clinical Guidance.  Key information includes:

“Philips advises that patients using recalled BPAP and CPAP devices should stop using their devices and consult with their medical providers to determine the most appropriate options for continued treatment, based on the benefits of continuing therapy and potential identified risks. The AASM suggests that the medical provider prescribe for their patient a PAP device that is not affected by the recall. However, in the case that this is not an option, or another device is unavailable, then it is the AASM viewpoint that clinical factors such as comorbidities, severity of symptoms, risks associated with PAP discontinuation, and safety-sensitive roles should inform the decision to continue or discontinue therapy. This decision should be made in concert between the patient and their medical provider. The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources. The AASM advises that patients contact their medical provider as soon as possible to discuss whether to continue or discontinue treatment.”

Philips PAP photos

Some DreamStation PAP Devices are included in the recall

Devices affected by the recall include the popular DreamStation CPAP, Auto CPAP and BiPAP units.  The newer DreamStation 2 is not affected.

If you use a Philips device, please contact Philips at Philips Recall Information or (877) 907-7508.  If you are an Advanced Sleep Medicine Services patient and need additional assistance after contacting Philips, please contact us at customerservice@sleepdr.com or (877) 775-3377.

Comments

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