The U.S. Food and Drug Administration (FDA) has issued a safety alert to patients, caregivers, and healthcare professionals concerning Philips Respironics (Philips) new breathing machine mask recall. The safety recall involved masks that are used with certain Philips continuous positive airway pressure (CPAP) machines and bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines. The recalled […]
The U.S. Food and Drug Administration (FDA) has issued a safety alert to patients, caregivers, and healthcare professionals concerning Philips Respironics (Philips) new breathing machine mask recall. The safety recall involved masks that are used with certain Philips continuous positive airway pressure (CPAP) machines and bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines. The recalled masks contain magnets that can cause injury or death when the magnets interfere with some implanted metallic objects and metallic medical devices in the patient’s body. These adverse possibilities can happen in patients who use the affected masks or in people who are near a person using the recalled masks. The recalled Philips masks can be used with other manufacturers’ CPAP and BiPAP breathing machines. Those who use BiPAP or CPAP machines should look to see if their mask has been recalled.
The recalled masks have magnetic headgear clips that hold the mask in place and are for single-patient use in the home or clinical environments. These recalled Philips masks are used by patients who weigh more than 66lbs (30kg) except for the Therapy Mask 3100 NC/SP and the Wisp Youth Nasal Mask. These two masks are used for patients seven years of age and older.
The recalled breathing machine masks include:
The news report states that the recalled masks have magnets that can cause injury or death if the user or a person near the patient has one of the following metallic objects in the body or implanted metallic medical devices:
Should these magnets induce movement or affect the functioning of particular metallic objects in the body or implanted metallic medical devices, the possible risks could include:
According to the FDA, Philips is required to provide medical device reports (MDRs) when there is reason to believe that their medical devices may have contributed or caused serious injury or death or malfunctioned and a similar device they make could cause or contribute to serious injuries or death if a similar malfunction were to happen. Patients, healthcare professionals, and consumers are able to submit device adverse events and malfunction reports to the FDA.
Philips has reported that there have been at least fourteen serious injuries related to the use of these recalled masks. The reports included a need for shunt adjustment, pacemaker failure leading to pacemaker replacement, arrhythmia, automatic implantable cardioverter defibrillator reset, headaches, cognitive changes, and changes in the heart rate (bradycardia, tachycardia), seizures, convulsions, and irregular blood pressure.
However, it is possible that there is an under-reporting of adverse medical events, a lack of verification that the device caused the reported event, inaccuracies in reports, and missing information concerning important details such as the frequency of device use. These limitations are the reason why MDRs comprise only a portion of the FDA’s important postmarket surveillance data sources. MDRs, along with other data sources, contribute important details to a medical device’s benefit-risk assessment. The FDA reviews and assesses the MDRs to keep the public informed when new information is available.
Recommendations for Caregivers and Patients
Recommendations for Health Care Providers
The FDA acknowledges that patients depend on these medical devices, and the agency is closely monitoring Philips’ actions to make sure that the issue is resolved. The FDA will work with Philips to make certain that the company takes proper steps to rectify the recalled devices.
The FDA is evaluating the health hazard raised by using the recalled devices, reviewing Philip’s strategy to address the issue, and taking additional measures when appropriate. The FDA is also evaluating the safety of these magnets used in masks or similar interfaces used in sleep medicine and their impact on patient safety. The FDA plans to caution these manufacturers and take critical measures to manage any issues. According to the FDA, the agency will keep the public updated.
Did you or a loved one sustain harm due to a recalled magnetic mask? Parker Waichman LLP helps those who have suffered product injuries receive full monetary compensation. Trust your case with our product injury lawsuit lawyers. For a free consultation, contact our law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).