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

[Tampa Jim]

We're both eligible for new units. Off to the MD for our DME Rx. Done, done and done.

[Homerec130]

We got the notice from them the are having problems reaching out to our doctor to get a script so they can send a replacement unit. Got a call from the doc and she told us she told them she was not prescribing Phillips products for any of her patients.

[Rich66]

I use an ASV machine. My original issued machine was a PR System One 60 series machine that was outdated from when I first got it -- typical terrible DME service taking advantage of a newbie. I signed up for the recall the minute it was posted. Luckily, I had switched to a Resmed before the recall. It has been a couple of years since then. I received notices from them that they considered my machine was past its useful life and that I could get $50 if I wish. I never responded back on those offers. Just a month ago, I received a Dreamstation One delivered to my house -- with everything I need but a modem. Phillips won't give me a modem, the DME won't give me a modem -- they point the finger at each other. The machine appears in good shape with no hours on it. And it is an ASV.

[Labromaniac]

I have the exact same situation as you. I just got the same deal in a big box as well. I wish I had taken the $50. I have already given the refurbished Dream Station One machine away and have been happily using the Resmed ASV ever since the recall and my results have been vastly superior to when I was using the Phillips System One ASV. Alas. I am using the included free mailing label to return my very old System One ASV which has been gathering dust on my closet shelf and thus THEY can dispose of it in their landfill and at their cost. Sad situation all these years eh?

[TimaaaaaaaahRocks]

Looks like somebody found a source for lower-cost turbine bearings. Enjoy your promotion while it lasts, buddy!

• Motor problem, heating element, or crap electronics?   From the FDA bulletin:
  
  
  • Unplug the CPAP machine and do not use it if:
    
    
    • you smell burning, smoke, or any unusual odors,
      
    • there is a change in the appearance of the CPAP machine,
      
    • there are unexplained changes to the CPAP machine’s performance,
      
    • water is spilled into the CPAP machine,
      
    • you hear unusual sounds coming from the CPAP machine.
      
  How could spilling water into a correctly IP rated device cause a problem unless...wait for it...the IP rating is incorrect for the device. Regardless to say they replaced one POS design with a more profitable POS design. 

---

The FDA warning sounds like an advertisement for the HAPPY FUN BALL!

Warning: Pregnant women, the elderly, and children under 10 should avoid prolonged exposure to Happy Fun Ball.
Caution: Happy Fun Ball may suddenly accelerate to dangerous speeds.

1. Happy Fun Ball contains a liquid core, which, if exposed due to rupture, should not be touched, inhaled, or looked at.
   
   
2. Do not use Happy Fun Ball on concrete.
   
   
3. Discontinue use of Happy Fun Ball if any of the following occurs:
   
   • itching
     
   • vertigo
     
   • dizziness
     
   • tingling in extremities
     
   • loss of balance coordination
     
   • slurred speech temporary blindness
     
   • profuse sweating or heart palpitations.
     
4. If Happy Fun Ball begins to smoke, get away immediately. Seek shelter and cover head.
   
5. Happy Fun Ball may stick to certain types of skin.
   
6. When not in use, Happy Fun Ball should be returned to its special container and kept under refrigeration. Failure to do so relieves the makers of Happy Fun Ball, Wacky Products Incorporated, and its parent company, Global Chemical Unlimited, of any and all liability.
   
7. Ingredients of Happy Fun Ball include an unknown glowing green substance which fell to Earth, presumably from outer space.
   
8. Happy Fun Ball has been shipped to our troops in Saudi Arabia and is being dropped by our warplanes on Iraq.
   
9. Do not taunt Happy Fun Ball.
   
10. Happy Fun Ball comes with a lifetime warranty.
    

   Happy Fun Ball! Accept no substitutes!  

[ST Dog]

• Motor problem, heating element, or crap electronics?   From the FDA bulletin:
  
  How could spilling water into a correctly IP rated device cause a problem unless...wait for it...the IP rating is incorrect for the device. Regardless to say they replaced one POS design with a more profitable POS design. 

---

I've never seen an IP rating for a CPAP machine.

Go look at the actual reports that they based that notice on. It's all garbage.
Run the humidifier dry and it will smell like burning plastic. That true of my PRS1, my DS1, and my AS10.

Spilling water around the humidifier chamber has always been an issue. 

I have yet to see a picture or video of the supposed problems.
You'd except there to at least be photos somewhere of burnt devices.

[TimaaaaaaaahRocks]

I've never seen an IP rating for a CPAP machine.

The User Manual for my AirSense 10 has the IP rating listed in the Technical Specifications section. Every regulated medical device has an inherent IP rating determined by the product's properties and usage environment. 

How does one perform a biocompatibility analysis on burning plastic emissions? They all may smell like burning garbage if you run 'em dry. However, respironics made the Executive decision to flip off the FDA for years, hence FDA may be more inclined to do their damn jobs for a change and take any and all complaints against respironics garbage seriously.

[BoxcarPete]

• Motor problem, heating element, or crap electronics?   

I said that because the FDA bulletin mentions that there were 30 occurrences of complaints related to overheating over a period of two years, which has increased to 270 events over a period of three months. That has me wondering if they suddenly replaced a component with a lesser substitute so they could avoid a manufacturer's price increase, shortages due to supplier problems, or they simply found a lower cost product somewhere else that they tossed in there mid-production.

[btreger]

PROPUBLICA


Millions of People Used Tainted Breathing Machines. The FDA Failed to Use Its Power to Protect Them.

The FDA’s complaint-tracking system for medical devices allowed Philips to obscure when it knew about dangerous CPAPs. New reporting shows that regulatory lapses extend to many devices and companies.

The FDA maintains that it acted as soon as it learned of the safety concerns in April 2021, just weeks before Philips launched one of the largest recalls of its kind.

But a ProPublica and Pittsburgh Post-Gazette investigation found that in the years leading to the recall, the FDA repeatedly failed one of its most critical missions: alerting the public about devices that can inflict serious harm. Over a decade, the agency missed a pattern of warnings from healthcare workers, patients, and others that something was wrong with the company’s popular sleep apnea devices and ventilators.

From 2011 to 2021, Philips sent hundreds of complaints about the machines to the FDA, none of which resulted in alerts to doctors or patients. One report described a “black powder substance” inside a ventilator. Another noted foam that was “loose and tangled.”

Scores specifically cited “contamination,” a red flag that experts say should have prompted an immediate inquiry because the machines send air directly into the noses and mouths of users, including infants and the elderly. It is unclear who, if anyone, read the reports at the agency.

How the FDA Failed to Protect Millions of People From Tainted Breathing Machines — ProPublica

[aergun]

I'm sorry if this is not the place for this subject.I decided not to return my Philips ASV and decided to keep it as a spare machine.However, when I opened the machine and cleaned it, I saw that the foam was extremely deteriorated.Can you suggest me a material that I can use instead of this foam? A few solutions written here did not make sense to me.