Tag: CPAP Recall
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...
In brief: Philips testing, F&P changes, Medline donation
July 26, 2023HME News Staff
AMSTERDAM – Testing on the impact of ozone cleaning on the Philips System One and DreamStation Go sleep therapy devices shows volatile organic compounds and particulate matter emissions related to foam degradation are within the applicable safety limits and are unlikely to result in appreciable harm to health in patients, the company announced July 24.
Additional visual assessments on used/returned first-generation DreamStation devices also confirmed the previously established low...
Philips provides additional testing results on devices treated with ozone cleaning
July 25, 2023HME News Staff
AMSTERDAM – Testing on the impact of ozone cleaning on the Philips System One and DreamStation Go sleep therapy devices shows volatile organic compounds and particulate matter emissions related to foam degradation are within the applicable safety limits and are unlikely to result in appreciable harm to health in patients, the company announced July 24.
Additional visual assessments on used/returned first-generation DreamStation devices also confirmed the previously established low...
Philips sees improvements in financial results
July 24, 2023HME News Staff
AMSTERDAM – Philips has reported 6% comparable sales growth for its Connected Care division in the second quarter, with double-digit growth in Monitoring, partly offset by a decline in Sleep & Respiratory Care.
Overall, the company reported group sales of EUR 4.5 billion and comparable sales growth of 9%.
“We are progressing to plan on our three priorities to enhance patient safety and quality, strengthen supply chain reliability, and simplify how we work, and I am pleased...
CPAP recall: When it comes to regaining trust, Philips has work to do
June 9, 2023Theresa Flaherty, Managing Editor
YARMOUTH, Maine – Two years after a recall wreaked havoc on the CPAP market, things have stabilized, but providers have mixed reviews on the way Philips handled the situation.
Philips first announced the recall of certain CPAP devices and ventilators in June 2021, sending providers on a rollercoaster of device shortages, confused patients, communication missteps and even recalls of reworked devices.
“Would I deal with Philips again?” said Tyler Riddle, president...
In brief: Optum makes play for Amedisys, FDA updates Philips report count
June 7, 2023HME News Staff
EDEN PRAIRIE, Minn., and BATON ROUGE, La. – Optum has submitted an all-cash proposal to buy Amedisys, despite Option Care Health announcing last month that it was merging with the home health and hospice provider.
“Amedisys’ commitment to quality and care innovation within the home, and the patient-first culture of its people, combined with Optum’s deep value-based care expertise can drive meaningful improvement in the health outcomes and experiences of more patients...
Philips on completed testing: ‘Assessments are positive and reassuring’
May 16, 2023HME News Staff
AMSTERDAM – Royal Philips has released a completed set of test results for the first-generation DreamStation, System One and DreamStation Go sleep therapy devices that indicate potential patient exposure to foam particulate matter (PM) and volatile organic compounds (VOCs) from the PE-PUR foam in these devices is unlikely to result in appreciable harm to health in patients.
The results, which have been shared with the U.S. Food and Drug Administration and other authorities, are the...