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Philips recall: FDA reviewing, assessing medical device reports 

May 24, 2022HME News Staff

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...

CPAP Devices, FDA, Philips Recall


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In brief: Invacare layoffs, Philips recall, ResMed exec

May 6, 2022HME News Staff

ELYRIA, Ohio – Invacare is streamlining its operations in the United States, primarily related to headcount reductions, to improve its cost structure, according to a May 4 filing with the U.S. Securities and Exchange Commission.  As a result, the company anticipates annual pre-tax savings of about $2.8 million, with about $1.9 million to be realized in 2022. It will incur restructuring charges of $800,000 and expects to make cash payments in the same amount, primarily related to...

Caire, Insulet, Invacare, Motion, Philips Recall, Quality Biomedical, ResMed, Rhythm Healthcare


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Vendors

Philips recall: FDA proposes new order

May 4, 2022HME News Staff

WASHINGTON – The Food and Drug Administration’s Center for Devices and Radiologic Health has proposed that an order should be issued to require Philips to submit a plan to repair, replace or refund the purchase price of recalled devices manufactured after November 2015.  The FDA says Philips has the right to an informal hearing prior to the agency’s decision on whether to issue the order.  The CDRH’s proposal is in addition to the FDA’s previous...

CPAP, Home Respiratory Equipment, Philips Recall


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CPAP therapy: Advanced capabilities complicate challenges

March 25, 2022Liz Beaulieu, Editor

YARMOUTH, Maine – A majority of sleep physicians and patients have been reluctant to prescribe and use different brands of CPAP devices, despite a recall and supply chain challenges that are limiting access to products, according to a recent HME Newspoll.  A big reason for that, respondents say: Philips and ResMed, which are the most widely prescribed and used, have the most sophisticated compliance tracking and reporting capabilities.  “Although many are upset with Philips,...

CPAP, Philips Recall


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In brief: Provider sues Philips, AZ MediQuip supports Ukraine, VGM launches tracker

March 18, 2022HME News Staff

PHILADELPHIA – Baird Respiratory Therapy has filed a lawsuit against Philips, claiming it and other DME suppliers are owed refunds for recalled respiratory devices containing PE-PUR sound abatement foam, according to Law360.   The complaint, filed March 9 in the U.S. District Court for the Eastern District of Pennsylvania, seeks class action status on behalf of all similarly affected suppliers, arguing that Philips breached its warranty and misrepresented the risk related to the foam...

aahomecare, AZ Mediquip, Baird Respiratory, Home Medical Equipment, Permobil, Philips Recall, Soleo Health, Ukraine, VGM


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DME provider files lawsuit against Philips

March 16, 2022HME News Staff

PHILADELPHIA – Baird Respiratory Therapy has filed a lawsuit against Philips, claiming it and other DME suppliers are owed refunds for recalled respiratory devices containing PE-PUR sound abatement foam, according to Law360.   The complaint, filed March 9 in the U.S. District Court for the Eastern District of Pennsylvania, seeks class action status on behalf of all similarly affected suppliers, arguing that Philips breached its warranty and misrepresented the risk...

Baird Respiratory, CPAP, Philips Recall


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Vendors

FDA to Philips: Improve communication on recall 

March 11, 2022HME News Staff

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,...

CPAP Devices, FDA, Philips Recall, ventilators


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Dan Starck

Providers

Apria CEO: ‘2021 was a banner year’ 

February 28, 2022HME News Staff

INDIANAPOLIS – Apria Healthcare has reported net revenue of $296.5 million for the fourth quarter of 2021, up 0.9% compared to the same period in 2020. Net income was $17 million vs. $25.9 million, down 34.5%.  The company reported net revenue of $1.15 billion for the full year 2021, up 3.3% compared to full year 2020. Net income was $64.9 million vs. $46.1 million, up 40.6%.  “We reported solid fourth quarter financial results and 2021 was a good year for Apria,”...

Apria Healthcare, COVID-19 Pandemic, Financial Results, Philips Recall


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Steve Griggs

Providers

AdaptHealth adjusts expectations for 2022

February 25, 2022Theresa Flaherty, Managing Editor

PLYMOUTH MEETING, Pa. – A larger than expected hit from the Philips CPAP recall in the fourth quarter of 2021 is creating an overhang on 2022, but AdaptHealth says it expects to take a significant share of the patient backlog when the situation improves.  The company had previously estimated the recall’s financial impact in 2022 to be in the neighborhood of $20 million, but said during an earnings call last week that number is closer to $65 million.  “It was...

AdaptHealth, CPAP, Home Medical Equipment, Philips Recall


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Steve Griggs

Providers

AdaptHealth booming, despite CPAP shortage, pandemic

February 24, 2022HME News Staff

PLYMOUTH MEETING, Mass. – AdaptHealth more than doubled its revenue in 2021, with reporting $2.45 billion, up from $1.06 billion in 2020.  “2021 was a remarkable year for AdaptHealth,” said Steve Griggs, CEO. “Despite the worldwide pandemic, the shortage of CPAP equipment, and higher costs from supply chain challenges, AdaptHealth has continued to grow and prosper. Although adjusted EBITDA fell short of our full-year guidance due to product mix shift from rental to...

AdaptHealth, CPAP, Home Medical Equipment, Philips Recall


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