Collection: FDA Safety Alert-Philips DreamStation 2 CPAP Machines

 

 

 

FDA Safety Alert-Philips DreamStation 2 CPAP Machines

CPAP EquipSource wants you to be aware of an important safety alert from the FDA regarding the Philips DreamStation 2 CPAP machines, which many of you may be using fo your sleep apnea therapy. This alert only applies to the DS2 model pictured above.

Recently, the U.S. Food and Drug Administration (FDA) issued a warning about potential overheating risks associated with these devices. Reports have indicated instances of fire, smoke, burns, and other signs of overheating. The FDA has observed a significant uptick in these reports, particularly between August and November 2023 with over 270 reports during that period alone compared with only 30 in the previous 3 years.

Click Here to View FDA News Release On This Important Warning

Here’s what you need to know:

  1. Inspection and Precaution: Before and after each use, inspect your CPAP machine for unusual smells, changes in appearance, or performance. These issues might only be noticeable when the device is running.
  2. Safe Operation Guidelines: Follow the manufacturer’s instructions carefully. This includes placing the CPAP machine on a firm, flat surface away from flammable materials, cleaning the device regularly, and allowing the heater plate and water tank to cool for about 15 minutes before handling.
  3. When to Unplug: If you detect burning smells, smoke, or unusual odors, notice any changes in appearance, hear strange sounds, or if water spills into the machine, unplug it immediately and cease usage.
  4. Health Care Consultation: If you cannot use your CPAP machine due to these issues, please consult your health care provider, such as your primary care physician or sleep doctor, to discuss your individual health situation.
  5. Reporting Problems: Any concerns, including unusual smells, sounds, or changes in appearance, should be reported to the FDA and Philips.
  6. Replace your CPAP machine with a diiferent brand if you are concerned that the Philips device is safe to use.

The FDA does not recommend discontinuing the use of these machines if you are not experiencing any issues. However, your safety is our top priority. We encourage you to take these precautions seriously and to stay vigilant while using your Dreamstation 2 CPAP machine.

Click Here to See YouTube Video

Please call us at 1-440-625-0660 if you have any questions.

 

 

Introducing PAPrx

Online CPAP Prescription Renewal Service

Get Your New CPAP Rx Today for $179.99!

Replace your broken or upgrade an old cpap machine without having to see a doctor for a new prescription

If you want to get an updated Rx without all the hassle of a doctor`s visit, this service is perfect for you. Whether you have a broken CPAP, want to purchase a travel or backup machine, our PAPrx service is the easiest way to upgrade your prescription online so you can buy the equipment & supplies needed to treat your sleep apnea and continue to get a good night`s sleep.

I Have Been on CPAP Forever, Why Is a Prescription Needed to Buy a New Machine?

Medical devices are regulated by the Food and Drug Administration and fall into one of three classifications. CPAP & BiPAP machines are considered Class II medical devices that require a valid prescription from a physician or a certified nurse practioner (CNP) to purchase. Every user has different therapy pressure settings based on the sleep study. The machines are programmed per your physician prescribed settings.

No Doctor Office Visit Required

We can save you time and money by connecting you with a licensed board-certified sleep physician that can assist you totally online. Simply submit your PAPrx Assessment Form along with the supporting documentation and let us do the rest. The whole process is done via electronic communication utilizing DocuSign`s e-signature secure platform and e-mail.

Replace an Expired or Lost Rx

Do you need to purchase a CPAP or BiPAP machine asap? Is your prescription old or lost? We can provide you with a new one online in as little as 1-2 days and sometimes the same day. Turnaround time is based on when our office receives the questionnaire and supporting documentation and the day and time your order was placed.

PAPrx is Perfect for CPAP & BiPAP Users That;

  • Are in between doctors, moved from another state or your doctor is refusing to write the prescription without seeing you first. You are not able to schedule an appointment asap and would have to wait months to get in.
  • Current machine is broken and you are in desperate need of a replacement.
  • Currently does not have a doctor that can write a CPAP or BiPAP prescription.
  • Suffer from severe sleep apnea, the therapy is critical to your health and well-being and an updated prescription is required to purchase a new machine. 
  • Is not going through insurance and paying out-of-pocket. Our prescription cannot be used by a DME company to bill your insurance carrier.
  • Have been diagnosed with sleep apnea through a sleep study in the past and does not want to go through the hassle, inconvenience and expense of another study.
  • Was a previous CPAP user and would like to restart their sleep therapy. Is a current and faithful user for many years of a CPAP or BiPAP machine to treat their sleep apnea.
  • Has an F.D.A issued recalled Phillips CPAP or BiPAP machine that are defective and you do not feel safe using the device and would like to purchase a different brand.
  • Has a job that requires CPAP use compliance to obtain their CDL. Their current machine is old and not working or has a corrupt pc board. Customer is unable to download the compliance data from the device to renew their CDL and needs a new machine.

    How Does PAPrx Work and What Can I Expect?

  1. Start by gathering the required document(s) to verify your sleep apnea diagnosis:  Please visit our store or call us at 1-440-625-0660 or send email to at orders@cpap411.com  to place an order. We will email you an invoice to submit payment of $179.99 for the service. Please call us if have any questions prior to placing the order.
  1. We will e-mail you a questionnaire to complete and sign: This is an electronic document from our DocuSign signature platform for you to complete and sign from a computer, smart phone or iPad. We normally email the questionnaire either the same day or within one business day of your order. Please plan on spending about 15 minutes to answer all of the important questions from the sleep doctor. You will submit payment of $179.00 after completing the questionnaire through the DocuSign payment portal and attach the proof of diagnosis noted below.
  1. Our Board-Certified Sleep Doctor Reviews Your Signed Questionnaire: After a thorough review of your answers on the questionnaire and supporting documentation, the sleep doctor signs off on the request. A copy of the prescription and questionnaire will be sent to you after the physician’s signature to make it official. Now you have what you need to purchase a new machine!

Documentation Requirements - CPAPrx Prescription Service
To be eligible for our prescription service, you must have undergone a sleep study in the past and have an official diagnosis of obstructive sleep apnea (OSA). You must be able to provide documentation that you have sleep apnea. We would accept any ONE of the following to process your order;

  1. Copy of an old sleep study with the interpretation and therapy recommendations noted.
  2. Any type of medical document that has your full name and a sleep diagnosis noted. The diagnosis code for obstructive sleep apnea (OSA) is G47.33.
  3. An old or expired CPAP or BiPAP prescription.
  4. A copy of a prescription that was obtained from the DME company that provided you with your old machine. You can call and request this document; they are required to provide a copy to you based on current HIPPA regulations.
  5. A doctors note with your name stating that you have sleep apnea (OSA).
  6. You can also check your online electronic medical record for this information.

 *** We are unable to accept your machine compliace data download report as proof of diagnosis.

Please NoteThe doctor will not review this order without the documentation requested above. If you are unable to locate this information, you will need to have a new Sleep Test performed by contacting your doctor. You can also purchase our Home Sleep Test (HST) service to order and test yourself at home. A new HST with us allows you the ability to purchase our PAPrx CPAP Prescription Service. To save money you can also take the test results to your doctor to review and write you a new prescription. A general physician needs to authorize cpap or bipap therapy for your newly diagnosed sleep apnea if clinically warranted based on the recommendations of the sleep doctor.

Our Goal is To Provide Convenience and Discretion
PAPrx is a service offered by CPAP EquipSource to provide convenience for our customers. We do not engage in the practice of medicine, and the issuance of a renewal prescription requires the discretion of a licensed and board-certified sleep physician based on the information and documentation that you provided.

If the sleep physician is unable to issue a renewal prescription, a full refund will be provided. 

I have never been diagnosed with Sleep Apnea. How do I get tested? 

If you have never been diagnosed with Sleep Apnea, we can help facilitate a Home Sleep Test (HST). Home sleep apnea testing devices are extremely accurate and you can avoid having to go in for an in-patient test in a lab or hotel room that nobody likes.

Our ResMed ApneaLink HST device is easy to use and more importantly is completed in the comfort of your own bed. We mail the test to your home or you can pick-up the device at our store. All you have to do is wear it one night for 5 hours and send it back to us. Our sleep doctor reviews the test and you will have the results in just a few days. 

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Why You Should Choose CPAP EquipSource for Your Equipment & Supply Needs: Service Lives Here!

We welcome the opportunity to provide you with competitive pricing for the equipment and supplies needed for your sleep therapy. CPAP EquipSource is a small family-owned retail CPAP and oxygen store based in Middleburg Hts, Ohio. Our team has earned over 100 5-star Google reviews. So, you can shop with confidence knowing that we are a trusted and honest business that will treat you right! 

We offer the convenience for customers that live within driving distance of our retail store, the ability to pick up the equipment and supplies that you need the same day without having to wait. Our showroom has multiple options of machines, masks, cpap cleaners and other accessories from the major brands like ResMed, Philips and Fisher & Paykel and others.  We carry the Inogen One Portable Oxygen Concentrators and supplies for oxygen therapy users along with nebulizer machines.

You can actually see what you are buying and ask questions so you can make an informed purchase as opposed to shopping online. We are always well stocked with the products that you need to stay healthy. We also ship anywhere in the USA and take phone and email orders. Please call us at 1-440-625-0660 or send us an email at orders@cpap411.com for pricing or if you have any questions.