Philips Respironics CPAP Mask Update:
Dear valued customer,
1800CPAP.com has been notified of a voluntary update involving instructions and labeling of specific masks. Please review the enclosed notification from Philips in detail. If you have questions or need support concerning this mask update, please, contact Philips’ customer service at 1-800-345-6443.
Message From Philips Respironics
Philips Respironics alerts customers worldwide of updated instructions and labeling of specific sleep therapy masks that contain magnetic headgear clips due to potential risk of serious injury
What is Philips Respironics’ notification in connection with its sleep therapy masks with magnetic clips about?
- This is a voluntary notification to inform users of specific sleep therapy masks containing such magnetic clips of the updated instructions and labeling. The already present warnings have been strengthened and contraindications have been added.
- Use of the mask is only contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted metallic medical devices/metallic objects that may be affected by magnets.
- These masks may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
Which masks are affected by this update? :
- Philips Respironics DreamWisp Nasal Mask
- Philips Respironics DreamWear Full Face Mask
- Philips Respironics Amara View Full Face Mask
- Philips Respironics Wisp and Wisp Youth Nasal Mask
- Philips Respironics Therapy Mask 3100 NC/SP
Is this the start of a field action to replace all masks with magnets that are in use?
- No, this is a voluntary notification to inform users of specific sleep therapy masks containing such magnetic clips of the updated instructions and labeling. The already present warnings have been strengthened and contraindications have been added.
- Patients should only stop using the masks with magnets if the implanted metallic medical device/metallic object is contraindicated against the mask magnets. These patients should consult their physician immediately to determine if another mask can be used for their therapy.
- The masks with magnets may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
Are Philips Respironics’ masks with magnetic headgear clips safe to use?
- Yes, these masks are safe and may continue to be used according to the updated instructions and labeling if patients or people in close proximity to them do not have implanted metallic medical devices or metallic objects in the body.
- The magnetic headgear clips are used to attach the headgear straps to the masks, which is a method that is commonly used in the sleep therapy devices industry. Such magnetic clips are also used in the wearable electronics industry.
- Patients should only stop using the masks with magnets if the implanted metallic medical device/metallic object is contraindicated against the mask magnets. These patients should consult their physician immediately to determine if another mask can be used for their therapy.
Does Philips Respironics’ portfolio also include masks that do not contain magnetic clips?
- Yes, Philips Respironics’ portfolio also includes sleep therapy masks that do not contain magnetic headgear clips.
Will Philips Respironics continue to distribute masks with magnetic clips?
- Yes, following the implementation of the updated instructions and labeling, Philips Respironics will continue to distribute masks with magnetic clips.
Why is Philips Respironics issuing this notification?
- This is a voluntary notification to users of specific CPAP or Bi-Level PAP therapy masks containing magnetic clips to inform them of the updated instructions and labeling, including the strengthen warning and added contraindication.
- All users should read and follow Philips Respironics’ voluntarily updated warning and added contraindication described in the notification.
- This represents a new and industry-leading practice.
What is the potential risk of serious injury that Philips Respironics is warning about?
- Use of the mask is only contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted metallic medical devices/metallic objects that may be affected by magnets.
- More than 17 million masks containing magnetic clips have been distributed by Philips Respironics to date. As of August 30, 2022, Philips Respironics has received 14 reports of patients suggesting that the mask magnets may have impacted their medical devices including pacemaker interference, pacemaker failure leading to replacement, need of shunt adjustment, resetting of automatic implantable cardioverter defibrillator, seizures, defibrillator shutting off periodically, arrhythmia, irregular blood pressure, change in heartbeats, and cognitive issues. Philips Respironics has not received any reports of patient death in connection with this matter.