[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS

[Helena]

I called to see if my father's CPAP was on the recall list. It is. The woman at Philipps said that they did not know when they would be shipping a replacement device, and that they would contact me when they know. She said they recommend discontinuing the device immediately, and to contact his doctor.

I will call the pulmonologist's office as soon as they are open.

Will post what the doctor's office says to do until the replacement arrives.

[mrmagloo]

Sure would be nice to hear what exactly they are sending out? DS2?? I kind of doubt they would start another run of the originals? But then again, not much that Philips does makes sense. And, I wonder if they are going to want the old ones back? Seems the labor for them to retrofit would not be worth the cost. Lots of unanswered questions remain...

[btreger]

Something about individual DMEs issuing recalls doesn't feel right;

The FDA in their initial statement and their most recent statement said that they would be the ones issuing the updates on recalls. To my knowledge, they have not issued any new update information.

DMEs only have information provided to them directly from Philips. Why isn't Philips issuing any kind of roadmap of their recall strategy if they now have one?



 

[Helena]

Called pulmonologist and Apria, and respiratory therapist with Apria. Looks like there are some hoops to jump through to get a new machine.

Resp. therapist with Apria said that the filter on the back of the machine will filter out the outgassing of the disintegrating foam. I do not see how this is possible.

Can someone post what they have done? Thanks.

[WakeUpTime]

Resp. therapist with Apria said that the filter on the back of the machine will filter out the outgassing of the disintegrating foam.  

Good for you that you, especially as a non-user (since it's for your dad), for recognizing that as an absurd idea.  The RT should be reported for that false information, but they'll likely now say that you misunderstood.  Besides, you have more important issues at the moment.

You could immediately look into having a post-device filter installed on your dad's machine.  There are other threads here that discuss that option.  There are others here, including myself, that have ordered a replacement device.  Not having insurance for my device purchase is both a curse and a blessing (when it comes to making quick purchases).  I've always thought that it was important to have a backup device anyway.  Besides, you may have read that Philips says it may take up to one year to replace all the affected faulty devices.

You're somewhat part of the second wave of recalled device users that are now more recently finding out about the recall, and that's both better and worse.  It's better because you have such a great deal more information available to study now, although little of it is from Philips.  It's a little worse though as there was/is a real "run" on some products that will help recalled device owners.  So you may need to try a little harder to get some products, whether it's anti-bacterial filters or a replacement device.  

You're in a great place to help your dad, has ApneaBoard's extensive user base might be able to assist with, and guide you through, some solutions.  You'll find many great threads outside of this general thread that may help you too.  We have to be careful that this one thread doesn't become a "catch-all" for everything that might be related to the Philips Recall.  Other threads cover more specialized focused subjects that allow readers to get knowledge and ideas faster, rather than having to go through 1000+ posts and 100 pages.

[SingingSam]

Helena, you're right that the intake filter does nothing to solve the problem.

The available options are summarized here:

http://www.apneaboard.com/forums/Thread-...#pid408030

I don't know whether your father's machine is a DreamStation or one of the older System One models. For those who are inclined to deal directly with the foam, it can be done with either machine. The System One foam is more accessible. 

The best noninvasive (to the machine) interim solution is to add an antibacterial filter between the machine and the hose. This solution probably requires turning off the humidifier. It is unclear how the filter affects pressure, air flow and sensor operation.

There are no perfect solutions for the interim period while we all wait for PR to start the physical process of replacing either foam or entire machines.

[Helena]

@WakeupTim and @SingingSam Thank you very much for your kind and helpful replies. I will keep reading and asking.

My father's CPAP is a System One.

---

Good for you that you, especially as a non-user (since it's for your dad), for recognizing that as an absurd idea.  The RT should be reported for that false information, but they'll likely now say that you misunderstood.  Besides, you have more important issues at the moment.

You could immediately look into having a post-device filter installed on your dad's machine.  There are other threads here that discuss that option.  There are others here, including myself, that have ordered a replacement device.  Not having insurance for my device purchase is both a curse and a blessing (when it comes to making quick purchases).  I've always thought that it was important to have a backup device anyway.  Besides, you may have read that Philips says it may take up to one year to replace all the affected faulty devices.

You're somewhat part of the second wave of recalled device users that are now more recently finding out about the recall, and that's both better and worse.  It's better because you have such a great deal more information available to study now, although little of it is from Philips.  It's a little worse though as there was/is a real "run" on some products that will help recalled device owners.  So you may need to try a little harder to get some products, whether it's anti-bacterial filters or a replacement device.  

You're in a great place to help your dad, has ApneaBoard's extensive user base might be able to assist with, and guide you through, some solutions.  You'll find many great threads outside of this general thread that may help you too.  We have to be careful that this one thread doesn't become a "catch-all" for everything that might be related to the Philips Recall.  Other threads cover more specialized focused subjects that allow readers to get knowledge and ideas faster, rather than having to go through 1000+ posts and 100 pages.

@WakeupTim and @SingingSam Thank you very much for your kind and helpful replies. I will keep reading and asking.

My father's CPAP is a System One.

[Helena]

Helena, you're right that the intake filter does nothing to solve the problem.

The available options are summarized here:

http://www.apneaboard.com/forums/Thread-...#pid408030

I don't know whether your father's machine is a DreamStation or one of the older System One models. For those who are inclined to deal directly with the foam, it can be done with either machine. The System One foam is more accessible. 

The best noninvasive (to the machine) interim solution is to add an antibacterial filter between the machine and the hose. This solution probably requires turning off the humidifier. It is unclear how the filter affects pressure, air flow and sensor operation.

There are no perfect solutions for the interim period while we all wait for PR to start the physical process of replacing either foam or entire machines.

Thank you very much for your kind and helpful post. I will read more here, and keep asking.

[SingingSam]

Helena, your father's machine's foam has 3 enemies: unauthorized cleaning methods, heat and humidity.

Discontinue any cleaning method that isn't given in the System One user manual.

Make sure the grey foam intake filter is always clean and thoroughly dry. A dirty filter makes the internal temperature rise. A damp filter raises the internal humidity.

The cooler the room the better. Healthy humidity is between 40% and 60%, which can be monitored with a hygrometer. The closer it is to 40% without going below the better.

If your father travels then keep the machine out of hot car trunks and interiors. If that isn't possible then try putting the machine in a cooler with some "blue ice".

[WakeUpTime]

Sure would be nice to hear what exactly they are sending out? ... would start another run of the originals?  

It would be great to know Philips' internal flowchart to understand their product replacement priorities.  
Philips will likely have to consider: 

• device series (DS2, etc.)
  
• series type (CPAP, BiPAP, etc.)
  
• machine age (2 months, or 14 years)
  
• country shipping logistics (U.S., Brazil, etc.)
  
• legal issues/influences in that country
  
• local country medical directives (replacement device approvals, etc.)
  
• customer-type (end-user, insurance company, hospital, DME, medical agency, sleep center, etc.)
  
• and of course - use of SoClean
  

But they'll have to cross-balance all that with available inventory and inventory in the pipeline.  It's my understanding that Philips' latest quote of peak production of new devices is near the end of this year - and that's a best case, although they acknowledge possible challenges due to chip shortages and other supply chain constraints.  Let's keep in mind that Philips has NOT yet received approvals of their 200+ U.S. FDA application for it's new foam and new foam replacements.

I can't imagine how they'll handle older device users,  This recall dates back to 2007-models.  Having a technician fully trained on those particular devices, and knowing that components are more than a decade old now with significant use (along with dirt, dust and faulty foam particles), would seem to be an inefficient process.  I've taken apart old computer boards, card inserts, etc.  It's an awful process and I relented to replacing with new instead.  Perhaps Philips will come to the same conclusion.