To All Our Patients,

As with everyone in our community, Quality DME was surprised on June 14th, 2021, by the news of an official Philips Respironics Voluntary Recall. Respironics informed us of an ongoing investigation into a potential issue with their products, but their decision to initiate the Voluntary Recall and its timing came without warning. 

We understand that much uncertainty and confusion surround the details of the Recall and the solutions available to patients. We have received hundreds of inquiries and expect there will be many more in the coming weeks. Due to the volume of inquiries, we will utilize these Emergency Newsletters as an effective way to keep all of our patients well informed and up to date with the latest news and guidance. 

It is important to note that this Recall is only affecting select Philips Respironics Brand CPAP, BiPAP, and Ventilator devices (Listed in our previous newsletter).  This Recall does not affect any ResMed or Fisher & Paykel Brand devices.  

Details of the Root Cause of the Recall: 

There are two issues related to internally used sound abatement foam in select Philips Respironics devices: 

  1. The foam may degrade into micro-particles which may enter into patients’ airways. Philips Respironics reports a low complaint rate of 0.03% in 2020 regarding this occurrence.  
  2. The foam may off-gas certain chemicals. Philips Respironics claims there are no reports of serious harm as a result of this issue.  

For the direct comment from Philips Respironics:  Click Here

Philips Respironics Recommend Action: 

The recall notification (U.S. only)/field safety notice (International Markets) advises patients and customers to take the following actions: 

  1. For patients using CPAP and BiLevel PAP devices: Discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.    
  2. For patients using life-sustaining mechanical ventilator devices: DO NOT discontinue or alter prescribed therapy without consulting physicians to determine appropriate next steps. 
  3. Philips is recommending that customers and patients halt the use of ozone-related cleaning products and adhere to their device instructions for approved cleaning methods. 
  4. Additionally, Philips is reminding customers and patients to review the age of their CPAP and BiLevel PAP devices, as they are typically recommended to be replaced after five (5) years of use. 

The Pending Solution: 

We are working diligently with our contacts at Philips Respironics to fully understand and prepare for the next steps in their Recall Process. While information is still limited, we have compiled the following information and guidance from Philips Respironics: 

  1. Philips is creating a registration process that will allow Patients, Users, or Caregivers​ to look up their device serial number and begin a claim if the unit is affected.  Online functionality will be available soon. For more information, call 877-907-7508 to speak with the Philips designated recall team. 
  2. We have heard mixed feedback as to whether claims processing is live and available or not. 
  3. Philips will offer a combination of device repair or device replacement to correct the recall issue. There is not yet any indication of how they will determine which units will undergo repair or replacement. 
  4. Philips has not clarified if the pending repairs and replacements will be coordinated directly between Philips and the patient or through a local DME (Quality DME). 

Quality DME Solutions: 

In cases of urgent need that require immediate corrective action, Quality DME will offer the following solutions.  These are solutions to help patients as they navigate through the regular Philips Respironics recall process. 

  1. Customers who have had their Philips Respironics devices for five (5) or more years are very well likely to be eligible for a new machine through their insurance. Contact your physician and ask that a new prescription be sent to us by email at [email protected] or fax at 703-288-4388. If you are unsure how long you’ve had your machine, email us at [email protected], and our representatives will respond with the necessary information. 
  2. Customers affected by the Recall can purchase a new machine from ResMed (alternative manufacturer) at a significant discount of $499.00 for a CPAP and $930.00 for a BiPAP. Please email [email protected] to initiate a cash purchase of a replacement machine. 
  3. We also have a limited quantity of Refurbished ResMed CPAP machines for purchase for $299.00. These devices have been thoroughly inspected and sanitized to tight compliance standards. Quality DME warranties these devices for 1-year from the date of purchase 

EDIT: Due to international constraints on the supply of CPAP and BIPAP devices, we can no longer offer out-of-pocket solutions.

We will continue to update you as more information becomes available. In the meantime, we’ve generated the following list of frequently asked questions (FAQS) to do our best to respond to the most common questions we are actively fielding. 

Frequently Asked Questions (FAQS): 

1. What does it mean?

Philips Respironics has issued a recall notification advising patients using their impacted CPAP/BIPAP devices to stop using them due to identified issues with a component in certain products. This recall notice is the first step in enacting a corrective measure to the affected devices. The details of the corrective action are forthcoming and will be shared with you as soon as we know more. 

2. What are the potential health issues, and have your patients reported any? 

We have not received a single complaint from our patients. 

Details of the hazard associated can be found in the FAQ from Philips here: Click Here.  

3. I’ve been having some symptoms of “X”, could this Recall issue be the cause?  

Details of the hazard associated can be found in the FAQ from Philips here: Click Here. 

4. What’s going to happen if I keep using my CPAP? 

Quality DME cannot speculate what will be the impact of continuing to use the device. Details of the hazard associated with the Recall can be found here: Click Here. 

5. What can my doctor do if Philips Respironics says that we should stop using our CPAPs? Should I contact my doctor or insurance? 

The Recall states that the patient should work with their physician to determine whether the risks of discontinuing therapy outweigh the risks of the Recall. It is ultimately up to the patient to decide whether they continue to use the device or not. 

Your physician will likely not be a part of the recall process and only needs contacted regarding your therapy. 

It is unlikely that your insurance provider is taking any action at this time. 

6. How do I know if my machine is a defective one? 

Call the Philips Respironics designated recall team at 877-907-7508 and give them the serial number. You may also reference the list from Philips here: Click Here

7. Do I have Dreamstation 2 device? 

A list of impacted devices is found here: Click Here.  

8. Do I need to get a new machine, or is it safe to continue using the recalled device? 

Philips Respironics has recommended that anyone using a CPAP/BIPAP on the recall list should stop using the device because it is not considered life-sustaining. Quality DME, Inc. cannot recommend whether you should continue using your CPAP/BIPAP device or not. That decision is ultimately up to the patient and/or their physician. We can only communicate accurate information regarding the Recall so patients can make a well-informed decision. 

Depending on the recall process, your affected device will be repaired or replaced. 

9. If patients have Moderate or Severe Apnea or serious conditions that CPAP treats, what are the patients’ options?  

Philips Respironics has recommended that anyone using a CPAP/BIPAP on the recall list should stop using the device because it is not considered life-sustaining. Quality DME, Inc. cannot recommend whether you should continue using your CPAP/BIPAP device or not. That decision is ultimately up to the patient and/or their physician. We can only communicate accurate information regarding the Recall so patients can make a well-informed decision. 

10. Are we getting new machines? Are you going to fix my machine? 

At this time, it is unclear whether there are plans for a replacement or repair of the affected devices. It is most likely going to be a combination of repair and/or replacement. The details of the corrective action are forthcoming and will be shared with you as soon as we know more. 

11. Will the replacement PAPs or fixes be done for free? 

Philips Respironics has not directly indicated whether there would be expenses associated with the repairs/replacements. Still, we suspect there will not be a cost for the repair/replacement to the customer. We are awaiting instruction on the repair/replacement process to know with certainty how this will proceed. 

12. What can I do in the meantime? 

We are hopeful that the corrective measures will be available soon to patients.  In the meantime, Quality DME is offering significantly discounted machines for those willing to pay for a backup device. Otherwise, we are all forced to wait until further guidance is available from Philips Respironics. 

EDIT: Due to international constraints on the supply of CPAP and BIPAP devices, we can no longer offer out-of-pocket solutions.

13. How does this affect my compliance? 

It is yet unclear whether private or Medicare/Medicaid will make exceptions in the case of this Recall. We will have to wait for action to be taken by the payors before knowing what impact this will have. 

14. I just received supplies for a Dreamstation. What am I supposed to do with them? 

To prevent disruption to the resupply program, we will continue to provide supplies on schedule. If at any time you wish to hold your program, email [email protected]. If you decide to purchase a ResMed device, it will include the tubing and filters necessary to operate independently. We suggest keeping your Dreamstation supplies to use after the recall activity concludes.

15. What if I have two machines, one from insurance, and I purchased one? 

We expect that all affected devices will be repaired or replaced regardless of how they were provided. 

16. Will I get a refund for my OOP cost if I return the recalled device? 

At this time, it does not appear that financial reimbursement is the corrective action that Philips Respironics is taking on the Recall. However, if you are actively renting your device and wish to return it, we will stop the rental upon receiving the device. If you are unsure whether your machine is under rental, email [email protected]. Note: machines more than 13 months old are always considered purchased and will not be in an active rental. 

17. How does the Recall affect my current rent-to-own? Am I still liable when I can’t even use my machine? 

It does not appear that this Recall will interrupt the billing process. While there may be interruptions to therapy, it does not add any additional costs to the total price of the machine. 

While your machine is labeled a rental, it is considered a long-term purchase. The best way to think of it would be as if a car you purchased with a loan needed to go to the shop for repairs. While the vehicle is serviced, you are still paying the car loan as it will eventually be yours to keep. That is how the rent-to-own works on your PAP device. 

18. How does this affect my warranty? 

It is unclear what impact this will have on your warranty. A replacement device will likely come with a new warranty. Repairs may or may not include an extended warranty. 

For now, the issues are not corrected under warranty replacement but by the Recall. 

19. Why did we not do anything when there was an announcement of an issue in April? 

In April 2021, Philips Respironics announced an investigation into potential issues with their devices, and it was not a formal recall. Any announcement about the ongoing investigation would have been speculative and inconclusive.   

20. Aside from email, how else would I get contacted regarding the updates? 

Because of the massive scale of this Recall, this and future Emergency Newsletters will be the primary source of updates moving forward. Once we know more about the Recall Process, we will adjust as needed. 

Closing: 

If you have an urgent need, please feel free to reach out, and we will be here to assist.  We thank you for your patience and understanding.  Quality DME will work tirelessly through this time to ensure that we provide you timely and accurate information and guidance regarding the Philips Respironics Recall. 

Kindly,

Mike Austin
President, Quality DME, Inc.

Copyright © 2021 Quality DME, Inc., All rights reserved.

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PHILIPS RESPIRONICS CPAP, BiPAP, and Ventilator Voluntary Recall Notice (Important Updates Part 6)
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