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(News)
– In the United States, up to 2 million people use the recalled Philips-made CPAP respirators – and they are struggling to get the devices repaired or replaced. The company has recalled a number of CPAP (continuous positive airway pressure) machines as well as BiPAP (two-stage positive pressure) machines and ventilators; the FDA has the full list here and Philips has it here. Black debris from polyester-based polyurethane sound deadening foam used in machinery can decompose and enter machinery airways, which can be inhaled or swallowed by the user. This can cause serious medical problems; the FDA classified the recall as Class I, the most serious class, which means that continued use of the devices could result in serious injury or death.
There have been over 1,200 device complaints and over 100 reported injuries. Philips plans to release repair kits (which will replace the foam with a silicone version) or replacement devices, but has so far only been able to produce 55,000 per week, which they cannot even ship because they don’t have the FDA yet. customs clearance, WBAL reports. He estimates that it will take a year to replace or repair all the machines, the the Wall Street newspaper reports. This has left many people with sleep apnea, who use the machines to make sure they don’t stop breathing at night, wondering whether to stop using their machines (and risk problems cardiac and pulmonary or uncontrolled blood pressure), continue to use them despite the risks, try to remove the foam themselves or buy expensive new ones without knowing if they will be reimbursed by the insurance. Those who choose the latter option may not even be able to find one to buy: increased demand has resulted in inflated prices and a shortage of machinery. (Read more stories about sleep apnea.)
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