Tag: DreamStation

Company has spent 18 months testing exposure to particulate matter and VOC emissions from degraded foam in its first-generation DreamStation CPAP devices It has shared test results and assessments with the U.S. Food and Drug Administration but does not have a timeline for when it will hear back  Right now, there are no changes to guidance for health care providers and patients  AMSTERDAM – Philips officials say a now completed set of test results and assessments of recalled...

AMSTERDAM – Exposure to particulate matter emissions from degraded foam in first-generation DreamStation devices is unlikely to result in harm to patients and exposure to volatile organic compounds is not anticipated to result in long-term health consequences for patients, according to the latest test results and assessments from Philips.  Additionally, presence of visible foam degradation in inspected returned devices was found to be low: Of 36,341 returned devices from the U.S. and...

AMSTERDAM – Philips Respironics has determined that exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not typically anticipated to result in long-term health consequences for patients.  The announcement comes after an assessment by an outside medical panel and Philips and is intended to give healthcare providers the most recent data. Overall guidance for physicians and patients in the recall notification remains unchanged.  At...

AMSTERDAM, the Netherlands – Philips does not anticipate a delay to its recall or replacement program as a result of a recent report from the U.S. Food and Drug Administration, the company told its provider customers in a Nov. 23 letter.  The FDA recently published the results of its inspection of Philips’ manufacturing facility, noting the silicone-based foam used in a singular, similar CPAP/BiPAP device marketed outside of the U.S. failed one safety test for the release of volatile...

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...

YARMOUTH, Maine – HME providers had far more questions than answers as they scrambled to field patient inquiries and craft game plans in the days following the news of a voluntary recall of Philips’ first generation DreamStation CPAP devices.  Philips announced the recall on June 14 to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in certain Bi-Level, CPAP and mechanical ventilator devices.  “We’re...

PETERSBOROUGH, N.H. – SoClean is standing by its CPAP cleaning device, after Philips said “unapproved cleaning methods, such as ozone,” may be exacerbating the degradation of sound abatement foam in its first-generation DreamStation product family.   Philips made the claim as part of a voluntary recall announced June 14 to address identified potential health risks related to the polyester-based polyurethane foam in certain Bi-Level CPAP, CPAP and mechanical ventilator...

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...

CAMBRIDGE, Mass. – There’s only a “small risk” that the sound abatement foam in the first-generation DreamStation is being compromised by outside factors, including ozone cleaners, but Philips has chosen to be proactive and fix or replace these CPAP devices in the U.S., says CEO Frans van Houten. The occurrence rate of deterioration of the foam is about 0.03%, based on internal user reports and testing, the company says. “The use of ozone is typically a U.S....