Tag: CPAP Recall
PSN Labs responds to Philips lawsuit
October 7, 2024HME News Staff
PITTSBURGH – PSN Labs has disputed claims made by Philips that the lab caused “significant damage” to the company by conducting “numerous egregious errors in its testing and analysis” related to recalled sleep and respiratory devices. In a response filed Sept. 27 in the U.S. District Court for the Western District of Pennsylvania, PSN says the company “has continued to mischaracterize testing results in an effort to conceal the ultimate foam degradation issue.”...
In brief: Industry’s warning, Philips’ lawsuit, AdaptHealth’s results, NSM’s potential sale
August 6, 2024HME News Staff
ARLINGTON, Va. – The now expired 75/25 blended Medicare reimbursement rates served as a lifeline for many HME companies in non-bid, non-rural areas and immediate intervention is needed to preserve this infrastructure that allows individuals to manage their medical needs at home, according to a new report from AAHomecare.
The report is based on a recent survey that found an overwhelming 93.5% of respondents have had to make difficult operational changes in response to the expired rates...
Philips blames lab for breadth of recall
August 5, 2024HME News Staff
PITTSBURGH – Philips says PSN Labs conducted “numerous egregious errors in its testing and analysis” related to the company’s recalled sleep and respiratory devices, causing it “significant damage.”
In a lawsuit filed July 29 in U.S. District Court for the Western District of Pennsylvania, Philips says PSN’s work was a big reason it initiated a worldwide recall of more than 15 million sleep and respiratory devices in June 2021 and that the company...
Philips to lay off hundreds, shift manufacturing operations
June 20, 2024HME News Staff
MURRYSVILLE, Pa. – Philips Respironics will cut 300 manufacturing jobs in Western Pennsylvania and relocate approximately 500 workers from its Pittsburgh headquarters to its two major plants in the nearby suburbs, according to local news reports.
Starting in the fourth quarter of 2024, the company will move workers to its centers in Murrysville and New Kensington, a move that is expected to take two years, according to the Pittsburgh Post-Gazette.
The company said it will...
Philips now has ‘clarity’ to rebuild
January 31, 2024Liz Beaulieu, Editor
AMSTERDAM – With a consent decree nearly finalized and a more streamlined product portfolio, Philips believes its sleep and respiratory care business “bottomed out” at EUR 1 billion in revenues for 2023 and will "build back from there,” says CEO Roy Jakobs.
The company announced on Jan. 29 that it has agreed on the terms of a consent decree with the U.S. Food and Drug Administration related to Philips Respironics and its recall of certain sleep and respiratory...
Philips posts FAQ on silicone foam
December 26, 2023HME News Staff
AMSTERDAM – Philips posted a new FAQ to its website on Dec. 22 that explains the use of silicone sound abatement foam in its DreamStation 2 and other sleep and respiratory devices that were remediated as part of its June 2021 recall. “We have received a number of questions about the silicone sound abatement foam used in repaired and new replacement devices, as well as widely in the industry,” the company states. “We believe it is important that patients, care providers...
FDA issues warning for DreamStation 2
November 29, 2023HME News Staff
AMSTERDAM – The U.S. Food and Drug Administration yesterday issued a safety communication to inform users of possible thermal issues with the Philips Respironics DreamStation 2 CPAP machine and to advise them to monitor the machines for signs of overheating.
The FDA recently received medical device reports (MDRs) associated with issues like fire, smoke, burns and other signs of overheating while using the machine. The agency is in ongoing discussions with Philips about...
FDA requests more testing from Philips
October 6, 2023HME News Staff
WASHINGTON – The U.S. Food and Drug Administration has requested that Philips conduct additional testing on the health risks related to the sound abatement foam in certain recalled Philips ventilators and BiPAP and CPAP devices.
“We do not believe that the testing and analysis Philips has shared to date are adequate to fully evaluate the risks posed to users from the recalled devices,” the FDA stated. “Although Philips concluded that the exposure to foam particles...
In brief: Philips refutes claims, MA premiums remain stable, NCPA supports CVS lawsuit
September 29, 2023HME News Staff
AMSTERDAM – Philips disagrees with “characterizations” in recent articles that the company knew for several years about problems with certain ventilators and sleep apnea devices.
ProPublica and the Pittsburgh Post-Gazette on Sept. 27 published an article saying that Philips knew about a dangerous breakdown inside its widely used ventilators and sleep apnea machines but waited years before recalling the devices in 2021.
In a statement, Philips said it had previously...
Philips reaches settlement related to CPAP recall
September 7, 2023HME News Staff
AMSTERDAM – Royal Philips has announced that the company and certain U.S. subsidiaries, including Philips Respironics, have reached an agreement to resolve all economic loss claims related to a voluntary recall of certain sleep and respiratory care devices.
The agreement, which is expected to be submitted to the U.S. District Court for the Western District of Pennsylvania later today and which is subject to that court’s approval, will provide predefined cash awards to all eligible...