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"Philips Respironics is in discussions with the (FDA) regarding the reports," it said. ... the DreamStation 2 is the successor of the DreamStation 1 machine which had used the problematic foam ...
The health regulator added that in 2023, between July and September, it received more than 7,000 medical device reports, including 111 reports of deaths related to the use of these machines.
Philips Respironics's products include devices for the diagnosis and treatment of sleep apnea including CPAP and bi-level non-invasive ventilation machines, oxygen concentrators for patients requiring supplemental oxygen, infant apnea monitors for infants at risk of SIDS, asthma treatment solutions and hospital ventilators.
After selling the company, McGinnis founded another medical device company called Respironics in 1976. In the early 1980s, the company developed a CPAP machine called the SleepEasy, receiving FDA approval in 1984. The machines were a commercial success and helped establish Respironics as a major player in the medical device industry. [3]
Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.PAP ventilation is also commonly used for those who are critically ill in hospital with respiratory failure, in newborn infants (), and for the prevention and treatment of atelectasis in patients with difficulty taking deep breaths.
In June 2021, Philips announced a voluntary recall of several of its Respironics ventilators, BiPAP, and CPAP machines due to potential health risks. Gradual degradation of foam in the devices, intended to reduce noise and vibrations during operation, could result in patients inhaling particulates or certain chemicals. [157]
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