Tag: Philips Recall
Philips completes testing for first-gen DreamStation devices
December 23, 2022Liz Beaulieu, Editor
Company has spent 18 months testing exposure to particulate matter and VOC emissions from degraded foam in its first-generation DreamStation CPAP devices
It has shared test results and assessments with the U.S. Food and Drug Administration but does not have a timeline for when it will hear back
Right now, there are no changes to guidance for health care providers and patients
AMSTERDAM – Philips officials say a now completed set of test results and assessments of recalled...
Philips continues testing for Trilogy 100/200
December 23, 2022Liz Beaulieu, Editor
AMSTERDAM – Philips officials say additional testing and assessments are needed for its Trilogy 100/200 ventilators after the polyester-based polyurethane (PE-PUR) foam in new and lab-aged devices failed ISO 10993 genotoxicity testing.
The company says “weight of evidence assessment” for the vents, which passed volatile organic compounds and particulate matter testing, as well as several biocompatibility tests, is ongoing to confirm or exclude potential risks for patients.
“The...
Philips: ‘We have better understanding of the potential health risks’
December 21, 2022HME News Staff
AMSTERDAM – Exposure to particulate matter emissions from degraded foam in first-generation DreamStation devices is unlikely to result in harm to patients and exposure to volatile organic compounds is not anticipated to result in long-term health consequences for patients, according to the latest test results and assessments from Philips.
Additionally, presence of visible foam degradation in inspected returned devices was found to be low: Of 36,341 returned devices from the U.S. and...
Providers on vents: It’s ‘very challenging to keep track of what’s happening’
December 16, 2022Theresa Flaherty, Managing Editor
Philips announced on Nov. 7 that it was temporarily pausing its Trilogy 100/200 remediation program while it investigates a limited number of complaints on these units.
The company then announced on Nov. 13 that it detected two issues with corrected Trilogy 100/200 ventilators following the complaints.
Philips plans to release an RP kit in the first quarter of 2023 and subsequently start to work with authorities to resume the remediation process.
YARMOUTH, Maine...
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...