Tag: CPAP Devices

WASHINGTON – The U.S. Food and Drug Administration says it received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the foam breakdown or suspected foam breakdown of recalled Philips BiPAP and CPAP devices. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers and patients. A wide range of injuries were reported in the MDRs, including cancer, pneumonia, asthma, other respiratory...

SAN DIEGO – ResMed reported revenue increased 12% to $864.5 million in its third quarter fiscal year 2022. The company reported revenue, excluding software-as-a-service, increased 18% in the United States, Canada and Latin America, primarily due to a recall by one of its competitors and a recovery of core sleep patient flow that has been impacted by the COVID-19 pandemic. “Our third-quarter results reflect strong performance across our business, resulting in double-digit top-line...

WASHINGTON – The U.S. Food and Drug Administration says efforts by Philips Respironics to notify patients and others of its recall of certain ventilators and CPAP and BiPAP devices and the risk of harm from the polyester-based polyurethan (PU-PUR) sound abatement foam used in those products have been “inadequate.”  The FDA on March 10 issued a notification order to Philips Respironics requiring the company to notify all device users, DME suppliers, distributors, retailers,...

AMSTERDAM, the Netherlands – Philips expects to share additional research and test data on patient risk from recalled CPAP devices and ventilators in the fourth quarter.  The company recalled certain devices, including the first-generation DreamStation CPAP devices, in June to address potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.  “When we announced the recall, we acted on the assumption of a worst-case...

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...