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Date Issued: September 6, 2022
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain masks used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets (placements shown by black circles in the picture below) and can cause potential injuries or death when use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body.
These potential adverse events can occur in people who use the masks, or in people near a person using the mask. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks.
The recalled masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are for patients weighing more than 66lbs (30kg), except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP which are for patients seven years of age and older weighing more than 40lbs (18kg).
The recalled masks have magnets that can potentially cause injury or death if people who use them, or people near a person using a recalled mask, have certain implanted metallic medical devices or metallic objects in the body, such as:
If the magnets affect the functioning or induce movement of certain implanted metallic medical devices or metallic objects in the body, the potential risks may include:
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 a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would likely cause or contribute to a death or serious injury if the malfunction were to recur. Health professionals, consumers, and patients may voluntarily submit reports of device adverse events and malfunctions to the FDA.
As of August 30, 2022, Philips reported 14 serious injuries and 0 deaths related to the use of the recalled masks. The reported injuries included pacemaker failure leading to pacemaker replacement, a need for shunt adjustment, resetting of automatic implantable cardioverter defibrillator, arrhythmia, cognitive changes, headaches, change in heartrate (tachycardia, bradycardia), convulsions (seizures), and irregular blood pressure.
Although MDRs are a valuable source of information, this passive surveillance system has limitations. The incidence, prevalence, or cause of an event cannot typically be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Because of these limitations, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device’s benefit-risk assessment. The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available.
The FDA recognizes that patients rely on these devices and is closely monitoring the company’s actions to ensure the issue is resolved given the impact on patients. The FDA continues to work with Philips to ensure the company takes appropriate steps to correct the recalled devices.
The FDA is assessing the health hazard presented by use of the recalled products, reviewing the strategy the company proposes to address the problem, and may take additional actions as appropriate.
The FDA is also evaluating the safety of magnets that may be present in masks or similar interfaces from other manufacturers that are used in sleep medicine and that may have the potential to impact patient safety. The FDA intends to alert these manufacturers if appropriate and take necessary steps to address any issues that may be identified.
The FDA will keep the public informed if significant new information becomes available.
If you think you had a problem related to 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 mail or fax the form.
Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities.
If you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center at 1-800-345-6443 or visit their website at www.usa.philips.com.
More information on medical device recalls, including What is a Medical Device Recall, is available on FDA.gov.
The .gov means it’s official.