Hertegonne KB, Rombaut B, Houtmeyers P, Van Maele G, Pevernagie DA. Positive airway pressure initiation: a randomized controlled trial to assess the impact of therapy mode and titration process on efficacy, adherence, and outcomes. Kushida CA, Berry RB, Blau A, Crabtree T, Fietze I, Kryger MH, Kuna ST, Pegram GV Jr, Penzel T. Validation of the System One RemStar Auto A-Flex for Obstructive Sleep Apnea Treatment and Detection of Residual Apnea-Hypopnea Index: A European Randomized Trial. Gagnadoux F, Pevernagie D, Jennum P, Lon N, Loiodice C, Tamisier R, van Mierlo P, Trzepizur W, Neddermann M, Machleit A, Jasko J, Pépin JL. Alternatively, you can set up prescriptions entirely via CO with no device touch.Ģ. Assumes acceptance of smart, default settings. So far the company has received limited reports of potential patient impact due to foam degradation.1. Philips added that environments with increased heat and humidity could also cause foam degradation. Potential health risks related to the affected devices include exposure to chemical discharges from the foam material and degraded sound abatement foam resulting from unauthorised cleaning methods, including the use of ozone. We have significantly increased our production, service and rework capacity, and further intensified our outreach to our customers and their patients.” “We are mobilised to deliver a solution to them as fast as possible. Royal Philips CEO Frans van Houten said: “We fully recognise that the timeframe for remediation of the affected devices places patients in a difficult situation. The aim is to finish the repair and replacement programmes in under a year. The company is in ongoing discussions with the FDA on other portions of the recall and mitigation plan.įurthermore, the company has plans for repair and replacement initiatives in additional countries and intends to commence them in most markets by the end of September. Philips also commenced the replacement of specific affected first-generation DreamStation CPAP devices in the country with DreamStation 2 CPAP devices. As part of the rework, which is expected to begin this month, the PE-PUR sound abatement foam will be replaced with new material.
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