Issue date: September 6, 2022

The United States Food and Drug Administration (FDA) is alerting patients, caregivers and health care providers that Philips Respironics (Philips) has recalled certain face masks used with bilevel positive pressure devices (also known as name of Bilevel PAP, BiPAP or BPAP) and continuous positive airway pressure devices. airway pressure (CPAP) machines due to a serious safety issue. The recalled masks have magnets (locations indicated by black circles in the image below) and may cause potential injury or death when use of a recalled mask with magnets interferes with certain implanted metal medical devices and metal objects in the body.

These potential adverse events can occur in people who use the masks or in people close to someone using the mask. Additionally, the recalled Philips masks can be used with BiPAP and CPAP devices from other manufacturers. Users of any BiPAP or CPAP device should check to see if their mask is among the recalled Philips masks.

Description of the device

The recalled masks are worn by a patient while using a BiPAP or CPAP machine and have magnetic clips to hold them in place. The recalled masks are intended for use by a single patient at home or for multiple patients in hospitals or other clinical settings. The recalled masks are intended for patients weighing more than 66 lbs (30 kg), except for the Wisp Youth Nasal Mask and 3100 NC/SP Therapeutic Mask which are intended for patients seven years of age and older weighing more than 40 lbs. (18kg).

  • Figure 1: Amara View Full Face Mask
  • Figure 2: DreamWisp Nasal Mask
  • Figure 3: DreamWear Full Face Mask
  • Figure 4: Wisp and Wisp Youth Nasal Mask
  • Figure 5: 3100 NC/SP therapeutic mask

Magnets in the recalled masks may affect certain metal medical devices or metal objects in the body posing a potential hazard

The recalled face masks contain magnets that can potentially cause injury or death if people using them, or people near someone using a recalled mask, have certain implanted metal medical devices or metal objects in the body, such as that :

  • Pacemakers
  • Implantable cardioverter defibrillators
  • Metal stents (such as aneurysm, coronary, tracheobronchial, and biliary)
  • Neurostimulators (such as hypoglossal nerve stimulators)
  • Magnetic metal implants, electrodes and valves placed in the upper limbs, torso, neck or head
  • Cerebrospinal fluid shunts (such as the ventriculoperitoneal shunt)
  • Aneurysm staples
  • Embolic coils
  • Intravascular Flow Disruption Devices for Intracranial Aneurysm
  • Metal skull plates, screws, burr hole covers and bone substitute devices
  • Ocular implants (such as glaucoma implants and retinal implants; intraocular lenses placed during cataract surgery are not impacted)
  • Certain contact lenses containing metal
  • Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing aids, and brainstem hearing implants)
  • Magnetic Denture Attachments
  • Implantable ports and pumps (such as insulin pumps)
  • Metal gastrointestinal clips
  • Certain metal joint prostheses
  • Devices labeled as magnetic resonance (MR) hazardous
  • Magnetic metal implants not labeled for MR or not assessed for safety in a magnetic field
  • Metallic flashes in the eyes
  • metallic shine in the body

If magnets affect the function or induce movement of certain metallic implanted medical devices or metallic objects in the body, potential risks may include:

  • For cerebrospinal fluid and ventriculoperitoneal shunts: potential increase in pressure on the eye or brain, which may be fatal.
  • For aneurysm clips: broken suture lines or clip separation, which can be fatal.
  • For pacemakers: heart block or irregular heartbeat, which can be fatal.
  • For automatic defibrillators: may not produce a shock, which may be fatal.
  • For neurostimulators: brain compression, convulsions or lead migration, which can be fatal.

Medical Device Reports

Manufacturers, such as Philips, are required to submit Medical Device Reports (MDRs) when information reasonably suggests that their device may have caused or contributed to death or serious injury, or has malfunctioned and that device or a similar device they manufacture could cause or contribute to death or serious injury if the malfunction were to occur again. Healthcare professionals, consumers, and patients may voluntarily submit reports of adverse events and device malfunctions to the FDA.

As of August 30, 2022, Philips has reported 14 serious injuries and 0 deaths related to the use of the recalled masks. Reported injuries included pacemaker failure resulting in pacemaker replacement, need for shunt adjustment, reset of the implantable cardioverter defibrillator, arrhythmia, cognitive changes, headache, change in heart rhythm (tachycardia, bradycardia ), convulsions (fits) and irregular blood pressure.

Although RDMs are a valuable source of information, this passive monitoring system has limitations. The incidence, prevalence or cause of an event generally cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reporting, lack of verification that the device caused the reported event and lack of information on details such as frequency of use of the device. Because of these limitations, MDRs are only one of many important sources of FDA postmarketing surveillance data. These reports, along with data from other sources, can provide important information for evaluating the benefits and risks of a medical device. The FDA continues to review and evaluate the MDRs and will keep the public informed as new information becomes available.

Recommendations for patients and carers

  • Stop using of the recalled mask and switch to a non-magnetic mask if available, if you or someone close to you while using the recalled mask has any of the implanted metal medical devices or metal objects in the body listed above which can be affected by the magnets in the masks.
  • Make sure the recalled mask is kept at least 6 inches away from metal medical implants, metal objects in the body, and medical devices that can be touched by magnetic fields.
  • Consult with your health care provider to determine if another mask can be used for therapy and to decide if your care and treatment plan needs to change due to this safety issue.
  • Contact your health care provider immediately if you experience any issues with your medical device and report the issue through the FDA’s MedWatch voluntary reporting form.
  • Contact Philips Respironics customer service at 1-800-345-6443 or visit their website at www.usa.philips.com for more information on non-magnetic mask options.
  • Properly dispose of the recalled mask once you have another replacement mask.
  • You can continue to use the mask, if you or someone close to you when using the mask reminded, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that can be affected by the mask magnets.

Recommendations for Health Care Providers

  • Tell patients to stop using of the recalled mask and switch to a non-magnetic mask if available, if they or someone near them while using a recalled mask has any of the implanted metallic medical devices or metallic objects in the bodies listed above that may be affected by the magnets in the masks.
  • Make sure the recalled mask is kept at least 6 inches away from metallic medical implants, metallic objects in the body, or medical devices that can be touched by magnetic fields.
  • Properly dispose of the recalled mask.
  • Discuss the health risks associated with the use of the recalled face masks with patients who may suffer injury or death due to magnets affecting the function or inducing movement of certain metallic implanted medical devices or metallic objects in the body.
  • Do not prescribe the use of the recalled masks to patients with any of the metallic implanted medical devices or metallic objects in the body listed above that could be affected by the magnets in the masks. Prescribers should also ask about anyone else who might be at risk of injury or death if they come near a recalled mask while it is in use.
  • If you experience any issues with a recalled mask or if you are treating a patient who has been affected, report the issue through the FDA’s MedWatch voluntary reporting form.

FDA measures

The FDA recognizes that patients depend on these devices and is closely monitoring the company’s actions to ensure the issue is addressed given the impact on patients. The FDA continues to work with Philips to ensure the company takes appropriate action to correct the recalled devices.

The FDA is evaluating the health hazard presented by the use of the recalled products, reviewing the company’s proposed strategy to address the issue, and may take additional action, if warranted.

The FDA is also evaluating the safety of magnets that may be present in other manufacturers’ masks or similar interfaces that are used in sleep medicine and may impact patient safety. The FDA intends to alert these manufacturers, as appropriate, and take the necessary steps to resolve any issues that may be identified.

The FDA will keep the public informed if significant new information becomes available.

Reporting Issues to the FDA

If you believe you have had a problem with the recalled masks, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form or call 1-800-332-1088 for more information on how to send or to fax the form.

Healthcare personnel employed by facilities subject to FDA user facility reporting requirements must follow the reporting procedures established by their facilities.

Questions?

If you need additional information or assistance regarding this issue, please contact the Philips Customer Support Solutions Center at 1-800-345-6443 or visit their website at www.usa.philips. com.

More information about medical device recalls, including What is a Medical Device Recall, is available at FDA.gov.