Sleep Apnea Patients From The Cleveland Clinic Want To Know When To Expect Their DreamStation Sleep Apnea Machine Replacement

Sleep doctors at the Cleveland Clinic who prescribed sleep apnea machines are concerned for their patients who have been without the device for over a year

Thursday, April 28, 2022 - Reports are surfacing that Phillips Respironics, the makers of the recalled Phillips DreamStation Sleep Apnea machine and other models, has failed to comply with the FDA's recall order and could be held accountable by the US government. More than one-third of the three million sound sleep machines have yet to be replaced by the company. Many people treat their sleep apnea machines as a life or death breakthrough medical device as it enables them to sleep soundly through the night and function at a high level the next day. People that have used sleep apnea machines in the past have said that using them has improved their performance at work, and their relationships with other people including their spouses and children. For the last one year plus, these same people have been told to put down their machine because it may be malfunctioning. Patients using the Phillips sleep apnea machines under recall have reported black particles in the machine's transparent breathing airway tube which could be toxic and also chemical smells and gasses. Most were hoping for a quick (one month or less) replacement as they were promised but the replacements are taking much longer.

Cleveland19.com, the news of record in Cleveland, Ohio, where the prestigious Cleveland Clinic is located investigated and found out that "More than 1 million patients wait on replacements for recalled Philips CPAP machines," as of today, Thursday, April 28, 2022. Doctors at The Cleveland Clinic have prescribed the Phillips Sleep Apnea machines to their patients that have been diagnosed with the condition but have had to turn around and warn them in writing to stop using the machines. Interestingly, C19 discovered that the number of machines subject to the recall represents about ten years of sales of the device and that the FDA recall was of Type 1, the most serious designation reserved for drugs and medical devices that can cause serious injury or even death. "According to the FDA's recall the foam used in these devices may break down and potentially enter the device's air pathway, releasing black debris or certain chemicals which may be inhaled or swallowed by the person using the device," C19 wrote. Hundreds of sleep apnea patients have filed Phillips CPAP cancer lawsuits against the manufacturer of the device seeking lump-sum monetary reimbursement for medical expenses, lost wages, and pain and suffering. The US Food and Drug Administration (FDA) and the Department of Justice (DOJ) have expressed concerns that Phillips Respironics has been less than forthcoming and have not honored the FDA's recall request. Medical Designs and Outsourcing.com wrote, "DOJ subpoenas Philips over Respironics recall; CEO addresses investigation." The DOJ has subpoenaed Phillips to supply information and is preparing to launch an investigation into Phillips's failure to honor its recall promises. It appears from statements mad by executives at the company that Phillips may be unable to fulfill all of its ten-year backlog of recall demands.

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