All articles tagged with #cpap machines
Researchers are conducting a third clinical trial for AD109, a drug that could potentially replace CPAP machines for people with mild obstructive sleep apnea. Developed by Apnimed, AD109 combines aroxybutynin and atomoxetine, and has shown promising results in improving sleep apnea symptoms. With 39 million Americans affected by sleep apnea, this drug could offer a more convenient treatment option.
A new drug, AD109, developed by Apnimed, could potentially replace CPAP machines for treating sleep apnea, offering a less cumbersome and more cost-effective solution. The drug, a combination of aroxybutynin and atomoxetine, has shown promising results in phase II trials, particularly for mild cases of obstructive sleep apnea (OSA), with no major side effects reported. However, concerns remain about its efficacy for severe cases and the absence of oxygen saturation data in the trials. A third trial is currently underway.
Philips, responsible for a global recall of sleep apnea machines due to defective foam, has been ordered to overhaul its manufacturing and quality control systems by federal officials. The company must also continue to replace, repair, or provide refunds to all U.S. customers affected by the defective devices. The settlement comes after years of delays in addressing the issue, with lawsuits filed by affected individuals in multiple countries. The FDA found instances where Philips was aware of the problem with its foam years before the recall, prompting the agency to order clearer information about the health risks of the products and increased outreach to affected customers.
Philips, responsible for a global recall of sleep apnea machines due to defective foam, has been ordered to overhaul its manufacturing and quality control systems by federal officials. The company must also continue to replace, repair, or provide refunds to all U.S. customers affected by the faulty devices. The settlement aims to address one of the biggest medical device recalls in history, which has been ongoing for nearly three years, and requires Philips to hire independent experts to vet the changes and meet safety requirements before resuming production at U.S. facilities.
The FDA has reported 561 deaths linked to recalled Philips devices used to treat sleep apnea and other breathing disorders, with over 116,000 medical device reports of foam breaking down in the machines. Philips has agreed to a $479 million settlement and will stop selling the machines in the U.S., while continuing to service existing ones. Users affected by the recall can file claims for financial losses, and the deadline for submissions is August 9, 2024. The settlement does not affect claims for personal injuries or medical monitoring relief, and Philips denies conclusive data linking the devices to the reported deaths.
Philips is halting sales of its sleep apnea machines due to concerns about potential cancer risks associated with the devices. The company had previously recalled over 5 million CPAP machines in 2021 after discovering that they were blowing gas and foam into users' airways, increasing the risk of tumors. The FDA and Justice Department have forced Philips to stop new sales until the issue is addressed. The company is facing over 700 lawsuits alleging that the devices caused patients to develop cancers and other health problems. The recall affects various CPAP and Bi-Level PAP devices, and affected consumers are advised to register their devices and review information provided by Philips.
Philips Respironics will stop U.S. sales of its ventilators and CPAP breathing machines after reaching a settlement with the FDA, following a recall of over 1 million machines in 2021 due to reports of blowing gas and foam into users’ airways. The company will continue servicing existing machines but halt new sales until certain conditions are met, with a settlement amount yet to be determined. The sales halt affects widely used CPAP and BiPAP machines, and the company has apologized for the harm caused to patients, while the FDA remains unsatisfied with the recall's status as of October.
Philips, the maker of millions of recalled sleep apnea machines, has agreed to halt sales in the U.S. under a tentative agreement with regulators, potentially costing the company nearly $400 million. The recall was due to risks associated with the breakdown of internal foam in the devices, leading users to inhale particles while sleeping. The company has set aside $393 million to address expenses related to the recall and has promised to prioritize safety and quality. The agreement, which is subject to court approval, requires Philips to continue servicing recalled machines in the U.S. but prohibits the sale of new ones until corrective actions are taken. The recall has led to frustration among patients, with reports of delays in obtaining refunds or replacement devices.
Philips, the company behind a global recall of sleep apnea machines, has agreed to stop selling the devices in the U.S. under a tentative agreement with regulators, potentially costing the manufacturer nearly $400 million. The recall, affecting over 5 million pressurized breathing machines, was due to risks of their internal foam breaking down over time, leading users to inhale tiny particles and fumes while they sleep. Philips has agreed to a consent decree with the FDA and the Department of Justice, and while it will continue servicing previously sold machines, it cannot sell new ones until it meets corrective actions laid out by the FDA. The company faces personal injury lawsuits and legal challenges in multiple countries over the devices.
The U.S. Food and Drug Administration (FDA) has issued a safety communication regarding Philips Respironics' DreamStation 2 CPAP machines used for treating obstructive sleep apnea. The FDA has received reports of thermal issues with the machines, including fire, smoke, burns, and overheating, leading to patient injuries. The agency is in discussions with Philips about mitigation strategies and is urging users to carefully monitor the machines for signs of overheating. This safety issue is separate from the June 2021 recall of Philips sleep therapy and respirator machines. The FDA believes the thermal issues may be due to electrical and/or mechanical malfunctions and will provide updates as more information becomes available.
An investigation has revealed that Philips Respironics, a manufacturer of CPAP machines used to treat sleep-related breathing disorders, including sleep apnea, concealed safety issues with its devices for years. The company made a critical change to millions of its breathing machines, leading to concerns about potential health risks for the approximately 8 million Americans who rely on these devices.
Senator Richard Blumenthal is urging the Department of Justice to take action against Philips Respironics after it was revealed that the company withheld over 3,700 complaints about faulty breathing machines for 11 years before issuing a recall in 2021. The machines, used by infants, the elderly, COVID-19 patients, and veterans, were found to release hazardous particles and fumes. The FDA has criticized the safety tests conducted by Philips and stock prices for the company's parent company, Royal Philips, fell by over 9% after the FDA's announcement. Blumenthal and other lawmakers are calling for immediate action to hold Philips accountable for its actions.
The FDA has issued a Class I recall for certain Philips Respironics DreamStation CPAP machines due to a programming error that could cause serious health problems or death. The machines help people with sleep apnea by keeping their airways open during sleep. Philips has received 43 complaints about the issue, but there have been no reported injuries or deaths. The recall involves 1,088 machines distributed from December 1, 2021, to October 31, 2022. Affected customers are encouraged to contact their healthcare provider for a manual reset of pressure or to wait for a replacement device.
The U.S. Food and Drug Administration has issued a new alert about Philips Respironics' continuous positive airway pressure (CPAP) machines, which were recalled in June 2021 due to foam inside the units breaking off and blowing into users' mouths. The repaired machines have also been recalled, as they were given the wrong or a duplicate serial number when Philips re-programmed them. The error can cause the devices to deliver the wrong prescription to sleep apnea patients, or fail to offer any therapeutic benefits, which could lead to respiratory failure or heart failure. Philips has received 43 complaints about the reworked machines, although no injuries or deaths have been reported.