Tag: CPAP Devices

AMSTERDAM, the Netherlands – Philips reported EUR 4.2 billion in group sales for the third quarter, a 7.6% comparable decline due to headwinds caused by global supply chain challenges and the recall of certain CPAP devices and ventilators.  The company says comparable sales decreased 39% for its Connected Care business, following, in part, a double-digit decline in Sleep & Respiratory Care in the third quarter.  “This quarter’s sales were impacted unfavorably...

AMSTERDAM, the Netherlands – Royal Philips has received authorization from the U.S. Food and Drug Administration to begin replacing the sound abatement foam with new material in certain sleep and respiratory care devices starting this month.  The company has also started replacing certain affected first-generation DreamStation CPAP devices in the U.S. with DreamStation 2 CPAP devices, which aren’t affected by the recall.  “We fully recognize...

WASHINGTON – Sen. Richard Blumenthal, D-Conn., sent a three-page letter to Vitor Rocha, the CEO of Philips North America, on Aug. 24, asking him to answer seven questions, including, when does Philips expect to have repaired or replaced all impacted devices?  Blumenthal writes that he has heard from constituents with concerns about the lack of information surrounding a recall of certain Philips CPAP devices and ventilators announced in June.  “The current situation is...

AMSTERDAM – Philips could hear back from the U.S. Food and Drug Administration in August about its plans to replace the foam in certain CPAP devices and ventilators, based on a timeline provided during the company’s July 26 conference call to discuss financial results for the second quarter.  Philips filed "multiple packages" of CFR 806 applications for corrections and removals with the FDA in June and CEO Frans van Houten said, based on prior experience, there’s typically...

DARIEN, Ill. – The American Academy of Sleep Medicine will host a live panel discussion on Friday about the impact of the Philips PAP device recall notification on vulnerable populations, including pediatric and vent patients.  The discussion, from 3 p.m. to 4 p.m. ET, will cover:  Allocation of limited supplies – How to prioritize the medically most needy given the limited supply of home ventilators for patients needing them.  Respiratory therapy in hospitals...

AMSTERDAM – Royal Philips has announced, in consultation with regulatory agencies, a voluntary recall notification on certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.  The majority of affected devices within the advised five-year service life are in the first-generation DreamStation product family, the company says.  “We...

WASHINGTON - Walmart has removed CPAP devices from its website, after hearing concerns from AAHomecare. Last week, the association had sent a letter to Walmart, reminding the retail giant that both federal and North Dakota laws prohibit the sale of CPAP devices without prescriptions. AAHomecare wrote the letter after a provider in the state, Sanford Healthcare, reported being approached by someone who had purchased a CPAP device from Walmart.com. North Dakota also requires that clinically trained...

When it comes to encouraging people with COPD to exercise, a mobile phone app with dialogue support works best, according to a study published in the Journal of Medical Internet Research. As part of the study, researchers reviewed three prototypes for mobile apps using different persuasive technology: dialogue support, primary task support and social support. They assessed opinions on these prototypes through 28 interviews with COPD patients, caretakers and healthcare professionals, and through 87...

SAN DIEGO - ResMed aims to blow up the market for travel CPAP devices with its soon-to-be launched AirMini, company officials said during a conference call Jan. 23 to discuss second quarter earnings.When an analyst on the call asked how big the market is for travel CPAPs, CEO Mick Farrell acknowledged that it's a “a very small niche,” but that HME providers and their customers are increasingly embracing cash sales, and that ResMed is ready to leverage that changing mindset.“We think...

AUCKLAND, New Zealand - The International Trade Commission plans to investigate certain sleep apnea devices manufactured by Fisher & Paykel, it announced Sept. 19. The investigation is in response to a complaint filed by ResMed in August seeking to ban imported products Simplus full face mask, Eson nasal mask and Eson 2 nasal mask, that it says infringe on various ResMed patents. That complaint came after Fisher & Paykel filed patent infringement proceedings against ResMed, saying that ResMed's AirSense...