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

[speed3914]

RE: >POST 1351

That post I created on 9/1 when 4 separate news agencies had written stories on how the FDA had cleared Philips to proceed with the repair and replacement of affected machines.

The Chief Security Officer, (CSO) I spoke with had no knowledge of the articles, so I e-mailed him the links to those stories.

Today I sent a new e-mail:

"I would appreciate some straight answers on this. The FDA has told the world that it was in control of the recall, and would let everyone know when Philips submitted a proposal it could verify and trust before it authorized Philips to do anything.

I know of a number of people that have been notified by Philips that their new CPAP machines were being shipped. Today I heard from one individual that has received a new Dream Station 2 this morning.

So please tell me what is going on, because the FDA has said nothing.........."

I also sent the same e-mail to The Public Health Program Manager for the AASM.

In the meantime, I can only wait and see if I get any responses.

FDA in control of anything?   Not at least for a year lol

[brianc18t]

after receiving my ds2 this morning - the issue of ozone use being a factor for early ds2 shipments has been questioned.

my registration has fact that i had not used ozone to clean the ds1.  on removal of my ds1 foam, i found it to be in perfect condition - only a thin deposit of white household dust on the end of the foam that faced the incoming air was found. 

discussion also mentioned retention of foam for evidence- mine is in plastic bag which i am keeping.

Any idea why you got one early on?  Do you have really bad sleep apnea?  Was your machine 5 years old?  Can you think of any other reasons why they selected you early on?  Just curious.

[Zalagar]

Honestly to me, from the reports I've seen of people getting new DS2's all seem to be Day one registered folks, almost seems like it's just going in order. There hasn't been any other common factor between them. SoClean, No SoClean, Ownership from Months to years, Most had no contact with Philips or their DME's. At this point, there is no way to know.

[Zalagar]

One thing I am curious of though, Those of you folks that received a DS2, did the Machines come programmed to the same settings as your DS1's? I'm curious if having your Modem card in the machine also affects replacements, Once my old DME went out of business, I yanked the modem out of my machine, had Zero need for it. I barely just recently put it back in the machine like last month just in case for the recall. I'm curious if they used the modem data from your registered machine to clone to settings on the replacement device, or if they are just shipping brand new machine with a APAP pressure range of like 4-20, or if they will tell you to contact your DME. I would think if you swap your modem to the new machine, then call your DME, they could change the settings for the folks that needed it. But it just makes me wonder for those without current DME's. I had no DME for 4 years once my original one went out of business.

[secretigoo]

I registered for the recall on the first day it was available to non-physicians.  I received notification that the DS2 was en route on 8/16 and they sent it expedited delivery.  It had instructions on returning my old DS (which was only barely a year old).  It also said that "A Sleep Coach will reach out to you in the near future, to see if you have any questions on your new Dreamstation 2 device.  We will be in touch to provide any help that you may need!"  Weeks later, I have received no call.

 They also provided this information:  You can also call into the Sleep Coaching Center at 1-800-644-3324 for any needed assistance.

[cathyf]

One note about the "old unit destroyed" aspect. There is a world-wide chip shortage, and it is possible that PR intends to recycle the electronics into new machines. I'm thinking of a process where they cut open the plastic case, de-install the electronics, clean the electronics well, and then use them to manufacture new blower assemblies with brand new plastic outer cases and approved foam. Also they could clean and reuse blower motors, but that's not so much an issue as there is no shortage of the simple mechanical parts of these things. I'm not sure how likely this is for a bunch of reasons:

1. If they said "recycling components" or "recycling electronics" many if not most PR patients would want to send in their old units so that other patients could get their replacements sooner. But it is clear that this whole recall process is being run by people who don't have the freaking foggiest clue about what it means to live with sleep apnea. Communication is not their strong suit!
   
2. They might be worried about liability with using the recycled electronics -- it's possible that degrading foam could damage the boards?
   
3. Theoretically they should have fully-functional assembly lines for manufacturing and assembling plastic case, electronics, foam into DS1 motor assemblies. But they are idiots, so they might easily have destroyed those setups and not thought of restoring them.
   
4. In the US this probably requires FDA approval, and similar regulatory approvals in other countries. It's not clear how much of PR's apparent idiocy is actually FDA idiocy and they aren't permitted to look smarter than the FDA. (Or, more precisely, the natural consequence of the FDA's stupidity is that they force their own stupidity upon everyone that they regulate.)
   

It seems to me like this would be a very viable replacement strategy. Given the videos I've seen of the DS1 teardowns, you could use a band saw to precisely cut apart the plastic case of the blower housing without damaging anything inside -- well except maybe foam! Then disassemble the insides, clean the electronics, sensors, etc, refurb or replace the motor. Then use the DS1 manufacturing equipment to build new blower assemblies with new safe foam and new plastic cases. This gives you sealed blower units which could be sent to DMEs who would swap in the new blower units into current customers' machines (all you people who did tear-downs -- would this be as simple as it looks, and any reasonably competent repair technician could do this with simple tools like screwdrivers, pry tools, etc? I've done lots of simple electronic repairs, and there's definitely a level of replacement which does not require significant skill. I'm thinking that it's like replacing a failed disk drive in a computer -- you pull out the fully-assembled drive and replace it with a new one, which is orders of magnitude simpler than actually tearing into the disk drive and attempting to repair.)

If the DMEs were involved in the process, then the replaced motor housings could be sent back to PR for recycling into the next batch of replacement motor assemblies.

[fredHa]

did the Machines come programmed to the same settings as your DS1's?

even though i planned to put newly received ds2 on shelf for backup- i dont like the ds2 for reasons stated earlier- i plugged it in to see how the menu worked.  first thing displayed was a wrong pressure of 4.0 and ramp symbol.  as i continued to explore, yfi bars displayed and pressure displayed correctly 12.0 and no ramp.  it seems to be ready to use.

for earlier query as to why i got an early ds2- not high risk- ahi 1.8 last night and used ds1 since 10/18/2019.  age >80 been a cpap user for almost 20 years.  order of getting ds2 seems to be weighted by recall registration date. 

as philips get returns of ds1 i think they will trash the Blower Box, Cover and Motor Assembly that have ozone or high heat tar foam and high hours Motors (> ~ 8K)- keep 100% of others, replace the foam using a more sophisticated cut closure method (like plastic welding) than us DIY folks and rebuild devices from that stock.  their service and tech manual requires a test setup using software regiment.  the receivers of the rebuilt ds1 will get a good a good reliable device fully certified as medical equipment.  with millions to do they will get a highly efficient process going and get their cost manageable or it will destroy them.

[SleeplessinPgh]

I just spoke to my DME, who said they are not involved in the recall.  Anything I hear or receive will come directly from Philips.  She added that's what they know at this point; it could change.

[MikeE3]

My new DS2 arrived yesterday. I don't plan on using it, I'll stay with the Airsense 10 I bought out of pocket. I may give it a try but until OSCAR supports it, I definitely won't consider using it regularly.

I'll probably have to go elsewhere on this forum and see if I can find out how to enter clinical setup mode, so I can set the pressures, etc. to what I'm currently using on the Airsense base on feedback from folks here on the forum reviewing my OSCAR data.

I'm not high risk, average AHI < 1. And I didn't register as a Soclean user (never used one). My DS1 is about 3 years old.

I don't think I should have to send it back. After all it's been fully paid for. Although I have no idea what I'd do with it if I kept it. Certainly not use it. I stopped that over a month ago.

Did you do anything else besides register and wait?  
No calls to Philips directly?  
No contacts with any insurers that might have motivated Philips?  
No help from a lawyer via registering with a class action?

If 'no' to all those, it'll be extremely interesting if a new DS2 arrives, without notice, along with a return label & box for your old DS1.  We'll all try to figure out their replacement program schedule.  

By the way, did you register as being a SoClean user?
Were you an early (first day) registrant?

It sure would be nice to have some insight into Philips' replacement schedule for users.  Perhaps as more users receive deliveries, that will provide more insight.

My answers are all NO. And I didn't register until weeks after the recall was announced and then just waited. No calls to DME or Phillips. 

• Did you register the new DS2?
  
• Did you notify your insurance company?
  
• Where was the new device shipped from? 
  
• Was there a return address and was it prepaid?
  
• Did you notify your DME?
  

Didn't register new machine.
Didn't notify insurance company (Medicare)
Was shipped from Mt Pleasant, PA - about 300 miles from me (near Pittsburg, PA and I'm outside Philadelphia, PA)
Return prepaid label included, back to Mt Pleasant, PA
Did not notify my DME (actually have not had any contact with my DME re: this recall)

One thing I am curious of though, Those of you folks that received a DS2, did the Machines come programmed to the same settings as your DS1's? ....

No. It came with 'stock' documentation that implies when I turn it on my prescription will be downloaded to the machine. I don't know how Phillips would know what my current prescription is as it has changed since I initially got my DS1 and the DS1 was setup initially and then changed in the office by a tech who works there. The my prescription was changed again when I got my Resmed Airsense, that was pre-programmer when I picked it up from a different DME (than I used when I initially got the DS1) base on the newest prescription.

Sorry for the long post, have been away for a couple days, but wanted to answer folks who asked me questions.  Also won't have a chance to even turn the DS2 on until after the weekend as I'm leaving today for an out of town wedding.

[MikeE3]

Quick follow on ... my instructions also said '... please return for proper disposal'. Really? Or do they want to destroy the evidence? I get proper disposal, most electronics are not supposed to go out with your normal 'trash' pickups, so I'll get them a small break on that.