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Stock impact report

FDA issues safety warning over Philips DreamStation 2 CPAP machines [Seeking Alpha]

ResMed Inc. (RMD) 
Last resmed inc. earnings: 4/30 04:05 pm Check Earnings Report
Company Research Source: Seeking Alpha
In a statement released Tuesday afternoon , the FDA said it is recommending that users of the machines inspect them for unusual smells or changes in appearance before and after each use. The agency added that it is in ongoing discussions with Philips about mitigating strategies for the issue. The machines are used to treat obstructive sleep apnea. The FDA said that prior to Aug. 1, it had received less than 30 reports of thermal problems with the device since it was cleared for use in July 2020. From Aug. 1 to Nov. 15, the agency has received more than 270 reports, some of which cited patient injuries. The agency added that it is still monitoring Philips' handling of a recall in June for several models of its ventilators, BPAP and CPAP machines over concerns that the foam used inside the devices could break down and be potentially inhaled or swallowed by the user. It said that while the DreamStation 2 was not involved in that recall, the machines were distributed as a replacement Show less Read more
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