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To Our Valued Customers,
Philips-Respironics has opened a voluntary recall of certain CPAP, BiLevel PAPs, and mechanical ventilators.
We are further awaiting an action plan from Philips-Respironics.
You can find more information regarding the recall here.
The recall notification advises patients to take the following actions:
1. If you are using BiLevel PAP or CPAP devices to consult with your physician to determine the benefits of continuing therapy and potential risks.
2. If you are using a life-sustaining mechanical ventilator (Trilogy 100) device, DO NOT discontinue or alter prescribe therapy, without consulting physicians to determine appropriate next steps.
If you require additional information, please don’t hesitate to contact us at (909) 792-0909
Latest update:
UPDATE - December 22, 2022: The FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 2000 ventilators were recalled in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Additionally, Philips observed residual PE‐PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers. Read more in the safety communication for Certain Reworked Philips Respironics Trilogy 100/200 Ventilators Recalled Due to Potential for Silicone Foam Adhesion Failure and Residual PE‐PUR Foam Debris.
UPDATE - November 22, 2022: The FDA updated this safety communication to provide updated information about medical device reports (MDRs) received from August 1, 2022, to October 31, 2022, that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021.
On 8/2/2022, Philips has been asked by the FDA (Federal drug administration) to set your replacement CPAP for your recalled device with your pressure settings BEFORE shipping to you directly. Only your Durable Medical Equipment Providers (DME) were able to provide your settings directly to Philips but ONLY until August 30th. Our form is now closed. See the most recent update above.
On 6/7/2022, Philips keeps working on the device remediation. Priority goes to the devices with data synchronized to Philips - FDA does not allow Philips to ship machines with default settings. The patients have to receive the machines with their previous machine settings, and ready to use. In order to do that, Philips used data sent through CPAP machines with remote connection function via cellular or WiFi. These machines will be serviced quickly. If your machine does not have wireless connection, or your machine has hardware but your machine seller did not open an account at careorchestrator.com for you, you may wait a bit longer.
Obstructive Sleep Apnea
There's nothing like a good night's sleep. But for people with obstructive sleep apnea, decent shut eye is hard to get. They often snore and repeatedly stop breathing during the night. This not only causes daytime sleepiness, but also other health issues. Email RT@esphealthcare.net to schedule a Home Sleep Study (available in Hawaii) or to get a discounted CPAP or BiPAP Machine and supplies (Rx required).
Obstructive Sleep Apnea
There's nothing like a good night's sleep. But for people with obstructive sleep apnea, decent shut eye is hard to get. They often snore and repeatedly stop breathing during the night. This not only causes daytime sleepiness, but also other health issues. Email RT@esphealthcare.net to schedule a Home Sleep Study (available in Hawaii) or to get a discounted CPAP or BiPAP Machine and supplies (Rx required).
The MACRA Act of 2015, mandates Centers for Medicare & Medicaid Services (CMS) to remove Social Security Numbers (SSN) from all Medicare cards to address the risk of Medicare beneficiary medical identity theft. CMS will mail out new Medicare Cards to Medicare Beneficiaries starting April 2018 through April 2019.
For more information regarding the new Medicare cards, please visit the CMS website below:
https://www.cms.gov/medicare/new-medicare-card/nmc-home.html
For an overview of the new Medicare cards, please visit the CMS website below:
https://www.cms.gov/medicare/new-medicare-card/
New Medicare card resources:
For additional resources regarding the new Medicare cards, please visit the CMS website below:
https://www.cms.gov/Medicare/New-Medicare-Card/Partners-and-Employers/Partners-and-Employers.html
ESP Healthcare Group, LLC
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