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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
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10-28-2022, 04:12 AM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Received my replacement Philips Dreamstation last night here in West Oz. No drama. Easy free solution for posting the old one back too.
11-01-2022, 02:52 PM
(This post was last modified: 11-01-2022, 03:15 PM by WakeUpTime.)
WEEKLY RECALL NEWS REPORTS
"Sleep apnea device recall drags on, stoking frustration"
https://journalrecord.com/2022/10/25/sle...ustration/ "Philips faces more legal action for sleep apnea device recall" https://www.econotimes.com/Philips-faces...ll-1644336 "Recall Of Philips CPAP Device Causing Worldwide Shortage Of Devices" https://www.newsy.com/stories/recall-of-...ea-device/ Quote:U.S. officials are weighing unprecedented legal action to speed a replacement effort that is set to drag into next year.
11-09-2022, 12:05 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
New Orleans Injury Law News
legal examiner Philips To Pay Pay Millions to Resolve False Claims Act Allegations Philips will pay millions of dollars to resolve allegations that the company paid kickbacks to suppliers in exchange for them filing claims with the federal healthcare programs Medicare, Medicaid, and Tricare for Philips devices. Philips RS North America, a subsidiary of Philips formerly known as Respironics, will pay more than $24 million to the government. The settlement happened because a whistleblower came forward to report fraud. The manufacturer is also accused of giving suppliers access to prescribing data for free to help them market devices to physicians. According to the Justice Department, Philips provided illegal incentives to durable medical equipment (DME) suppliers. In return, the suppliers submitted claims for CPAP and BiPAP machines, ventilators, oxygen concentrators, and other medical devices. This behavior violates the Anti-Kickback Statute, a law that forbids paying remuneration for patient referrals if federal healthcare programs are involved. Both those who pay kickbacks and those who receive them can be held liable, and violators may face fines and jail time. Philips To Pay Pay Millions to Resolve False Claims Act Allegations (legalexaminer.com)
11-14-2022, 11:24 AM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RTL
LUXEMBOURG - FAULTY RESPIRATORS More than 1,000 Luxembourgers affected by Phillips product recall Author: Fanny Kinsch - adapted for RTL Today|Update: 14.11.2022 08:32 Even though the recall was done on June 14, 2021, it seems that some customers were not warned about the issue with these devices, which are usually used for sleep apnea. At the end of October this year, patients' representatives, therefore, drew attention to the product recall. As a result, one person came forward for using one of the affected respirators but not have been informed about the defect. Spokesperson Georges Clees elaborated: "We realized that nothing had yet happened in Luxembourg, nobody was made aware of the defect. We then immediately announced the issue on Facebook and on our website to inform people. We also sent emails to the Ministry of Health and the Health Directorate to monitor the case's progress." Hospital Federation FHL was only made aware of the product recall last week, says secretary general Sylvain Vitali: "According to the information given to us by the Health Directorate, there are more than 1,000 patients here in the country that use such a device. In cooperation with [National Health Fund] CNS, we are now contacting all of them to repair or replace the devices." Two out of four Luxembourgish hospitals have been affected by the recall. According to initial statements from the Ministry of Health, 873 devices were involved at the Centre Hospitalier du Nord (CHdN), but it now turns out that the Robert Schuman Hospitals also received faulty devices. RTL Today - Faulty respirators: More than 1,000 Luxembourgers affected by Phillips product recall
11-15-2022, 03:34 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
The New York Times
Frustrations Grow Over Company’s Response to Breathing Device Recalls Lawsuits claim the company, Philips Respironics, knew of problems with its CPAP and other machines long before notifying customers of potential health risks. By 2015, Philips Respironics knew its breathing devices had a problem: Foam inside the CPAP machines, which help people with sleep apnea breathe at night, was breaking off into black flecks and blowing into the mouths and noses of users. The company did nothing at the time. Years went by as complaints mounted, and the company made cursory efforts to examine the problem, according to an investigation conducted later by the Food and Drug Administration. As the recall unfolded, doctors said they were ill-equipped to balance the risks of the toxic chemicals against those of letting interrupted breathing go untreated, which can heighten the risk of cognitive decline, heart problems, and death. Device users have despaired over the difficulty of getting a replacement device or have bristled at deliveries of reconditioned models, which the company said account for about half of the replacements. The FDA review of company records showed that by 2015, the company had information from complaints, test reports, and suppliers that the foam in the devices was degrading. Yet it “failed to adequately evaluate” the information or mitigate the problem, the F.D.A. noted. In 2016, emails and test reports showed Philips learned that the foam could break down in as little as a year, F.D.A. records say. By 2018, a company engineer noted that the foam breakdown in a Philips ventilator was “not a good situation for” device users according to an email submitted in a lawsuit against Philips. Frustrations Grow Over Philips’s Response to CPAP Device Recalls - The New York Times (nytimes.com)
11-15-2022, 09:38 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Great! Thanks for your patience with me as I work through all this!
11-16-2022, 12:30 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Australian Government
Department of Health and Aged Care Philips recall action for CPAP, Bi-Level PAP devices, and mechanical ventilators - Update on Trilogy 100 Ventilators Product Defect Alert - New problems with corrected ventilators Philips Respironics (the manufacturer) has detected two problems with the corrected Trilogy 100 ventilators. What are the problems with the corrected Trilogy 100 ventilators? Problem 1 - Foam blocking the airway Problem 2 - Debris in the airway Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators - Update on Trilogy 100 Ventilators | Therapeutic Goods Administration (TGA)
11-19-2022, 12:48 PM
(This post was last modified: 11-19-2022, 01:20 PM by WakeUpTime.)
LATEST RECALL NEWS
(11-16-2022, 12:30 PM)btreger Wrote: Philips recall action for CPAP, Bi-Level PAP devices, and mechanical ventilators - Update on Trilogy 100 Ventilators Although the latest FDA alert issued (as a result of Australia's latest Philips defect alert) on the updated foam was for the Trilogy ventilators, isn't this the same updated foam used in the 4 million (so far) replacement devices issued? Quote:[November 18, 2022 https://www.medtechdive.com/news/philips...DA/636914/] Also... "Family says recalled breathing device caused Utah woman’s death" https://www.sltrib.com/news/nation-world...breathing/ Quote:By 2015, Philips Respironics knew its breathing devices had a problem: Foam inside the CPAP machines, which help people with sleep apnea breathe at night, was breaking off into black flecks and blowing into the mouths and noses of users. The company did nothing at the time. Years went by as complaints mounted, and the company made cursory efforts to examine the problem, according to an investigation conducted later by the Food and Drug Administration. "NBC 5 Responds to Consumer CPAP Machine Concern" November 18, 2022 | NBC Dallas https://www.nbcdfw.com/news/nbc-5-respon...n/3129467/ Quote:Philips offered two options: return the old machine for a $50 check or request a replacement device with a current prescription. Philips claims to have issued 4 million replacement devices, although they still can't seem to find a way to replace my recalled DreamStation APAP (purchased second-hand) and System One BiPAP (purchased new). They say I'm on the list and they regret the 18+ month (so far) delay. I was temporarily off the list while they awaited my response to their $25 offer for my Philips System One BiPAP. Perhaps I'm at the bottom of the list yet again.
11-19-2022, 04:49 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
Regard >above<
WakeUpTime Wrote: "Although the latest FDA alert issued (as a result of Australia's latest Philips defect alert) on the updated foam was for the Trilogy ventilators, isn't this the same updated foam used in the 4 million (so far) replacement devices issued?" The answer is yes. This was the FDA's response in their Update - November 17, 2022. No new updates have been issued to my knowledge on the silicone foam. Silicone-based Foam During the 2021 manufacturing facility inspection, the FDA obtained additional information, not previously available to the FDA, regarding the silicone-based foam used in a similar device marketed outside the U.S., which failed one safety test for the release of VOCs. Similar testing provided by Philips to the FDA on devices authorized for marketing in the U.S. had demonstrated acceptable results. The FDA has requested that Philips retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam. The FDA is aware that patients have already received devices with silicone-based foam as part of the repair and replacement program. Currently, while this independent testing is performed, the FDA does not recommend that patients who have participated in the repair and replacement program discontinue the use of their product. The FDA has reached this determination based on an overall benefit-risk assessment. At this time, the FDA has determined that discontinuing use of one of these devices may be more harmful to a patient's health and quality of life. The results from the independent testing are needed to determine if the silicone-based foam used in the repaired devices does in fact present any risks to patients, and the FDA will communicate those results to the public as soon as they are available. Patients who have additional concerns should talk to their healthcare provider about the plan for their care and treatment. Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication | FDA
11-19-2022, 08:28 PM
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
My replacement showed up on my porch yesterday. DreamStation 2. I bought a ResMed Airsense when the DreamStation recall began, so now I have my AirSense and a new DS2.
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