Tag: Philips Recall
In brief: Philips recall, catheter payments, Pottery Barn play
September 9, 2022HME News Staff
PITTSBURGH – Philips Respironics is alerting users of certain CPAP or Bi-Level PAP therapy masks with magnetic headgear clips or straps that these devices should not be used by or near patients and their household members, caregivers and bed partners who have metallic implanted devices or metallic objects (such as metallic splinters) in the body.
The magnetic headgear clips are used to attach the headgear straps to the masks, a commonly used method in sleep therapy devices.
This...
In brief: FDA update, F&P prediction, home infusion access
August 26, 2022HME News Staff
WASHINGTON – The U.S. Food and Drug Administration updated its safety communication for the Philips recall this month, saying it received more than 48,000 medical device reports, including 44 reports of death, associated with the foam breakdown or suspected foam breakdown in certain CPAP devices from May 1, 2022, through July 31, 2022.
The agency previously reported in May that it received more than 21,000 MDRs, including 124 reports of death, associated with the foam breakdown...
Philips recall: FDA continues review of medical device reports
August 22, 2022HME News Staff
WASHINGTON – The U.S. Food and Drug Administration updated its safety communication for the Philips recall this month, saying it received more than 48,000 medical device reports, including 44 reports of death, associated with the foam breakdown or suspected foam breakdown in certain CPAP devices from May 1, 2022, through July 31, 2022.
The agency previously reported in May that it received more than 21,000 MDRs, including 124 reports of death, associated with the foam breakdown...
In brief: Philips provides update, Tomorrow Health raises funds, Sen. Thune meets members
July 1, 2022HME News Staff
AMSTERDAM – A comprehensive testing and research program on the PE-PUR foam in certain CPAP, BiPAP and mechanical ventilator devices has shown very low prevalence of visible degradation, Philips announced in an update on June 28.
In first-generation DreamStation devices, which represent 68% of registered affected devices globally, testing found:
164 of 36,341 (0.5%) devices with self-reported no ozone use showed significant visible foam degradation.
777 of...
Philips provides ‘encouraging’ testing update
June 28, 2022HME News Staff
AMSTERDAM – A comprehensive testing and research program on the PE-PUR foam in certain CPAP, BiPAP and mechanical ventilator devices has shown very low prevalence of visible degradation, Philips announced in an update on June 28.
In first-generation DreamStation devices, which represent 68% of registered affected devices globally, testing found:
164 of 36,341 (0.5%) devices with self-reported no ozone use showed significant visible foam degradation.
777...
In brief: Oxygen NCD, Philips MDRs, Geffert’s new role
May 27, 2022HME News Staff
WASHINGTON – CMS has changed the implementation date of the new oxygen national coverage determination from Jun 14, 2022, to Jan. 3, 2023.
“This change only extends the implementation date to Jan. 1, 2023,” AAHomecare stated in a bulletin. “The new oxygen NCD coverage expansion will still be retroactively effective to claims with a date of service on or after Sept. 27, 2021.”
The new oxygen NCD, among other things, expands access for acute conditions...
Sleep industry grapples with shortages
May 26, 2022John Andrews
While supply chain delays have been a major choke point for the U.S. economy over the past year, the recall of Philips Respironics’ flow generators and masks has compounded the obstruction in the sleep therapy market. The ensuing vacuum created by the recall caused a ripple effect throughout the marketplace, causing various suppliers to scramble for ways to cover the shortage.
At this point, suppliers are still frustrated by a hardscrabble supply line, but remain hopeful that product...
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...
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...
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...