Philips Respironics CPAP Recall

[deedub75]

On June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.

The notification informs customers and users of potential impacts on patient health and clinical use related to this issue. Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material.  High heat and high humidity environments may also contribute to foam degradation in certain regions.

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

Has anyone heard from his or her sleep doctor or respiratory therapist? I have heard absolutely nothing from mine. I sent them a secure message asking them if they knew about it and if they did, why have I been contacted about what to do. Philips is saying to discontinue use of affected units and consult with physicians to determine the benefits of continuing therapy and potential risks.

[broncovet]

Good info.  I would call the help line on the website you indicated.  I did notice my cpap was noisier than when it was when new.  

Ask them what to do.  Tell them you cant do without your cpap, so they will have to send you a replacement device while yours is being repaired.  

[deedub75]

I just registered my device as my serial number is affected and this is what I got:

Thank you

What to expect next:

We regret that it may take some time to replace your device. The repair process for existing devices requires regulatory approval in your country, which we are working toward obtaining as quickly as possible. We will begin the repair/replacement process immediately upon that approval. We understand the impact of this issue on your therapy and we sincerely apologize for this disruption. It is our absolute number one priority to replace affected devices as quickly as possible.

For additional questions:

For more information and updates, please visit Philips.com/src-update where we will be updating answers to frequently asked questions (FAQ) as more information becomes available or call 1-877-907-7508 in the US and US territories or (0044) 20 8089 3822 outside the US. Thank you.

 

This is completely unacceptable on the part of Philips. Also the VAMC seems to have dropped the ball on this as there has been no notification to affected veterans that I am aware of. Hopefully, my sleep clinic will just replace mine with a ResMed. 

 

 

[deedub75]

13 minutes ago, broncovet said:

Good info.  I would call the help line on the website you indicated.  I did notice my cpap was noisier than when it was when new.  

Ask them what to do.  Tell them you cant do without your cpap, so they will have to send you a replacement device while yours is being repaired.  

It's not just the noise. Small bits of that soundproofing are breaking off and being breathed in. That soundproofing is also giving off toxic gases that are being breathed in.  

[pacmanx1]

12 minutes ago, deedub75 said:

I just registered my device as my serial number is affected and this is what I got:

The simplest way to resolve your problem is to call the VAMC Sleep Clinic because they issued you your device. They have the authority to replace your defective C PAP Machine. Explain to them that it is broken, and you need a replacement. They (The VAMC Sleep Clinic) may call you in or set up an appointment for you to come in. You can try them in the morning, I would not wait.

[deedub75]

Just now, pacmanx1 said:

The simplest way to resolve your problem is to call the VAMC Sleep Clinic because they issued you your device. They have the authority to replace your defective C PAP Machine. Explain to them that it is broken, and you need a replacement. They (The VAMC Sleep Clinic) may call you in or set up an appointment for you to come in. You can try them in the morning, I would not wait.

I sent them a secure message so they will respond and they will likely replace it. The point is that they should be alerting me about this issue instead of me telling them about it. It's not just defective - it could be a major health issue.