Just given a Phillips Dreamstation 2 the same day Phillips agrees to stop selling

[Montacute]

I am a new CPAP user and had a horrid first night.  I was looking for ideas to help when I found this forum.  My DME is Integrated Home Care and my copay was $50.  They brought the Phillips Dreamstation 2 to my house and showed me how to use it, no choice.  The pressure is on 40 and I have nasal pillows.  Lo and behold I read online today about it and see 2 things

1.  Phillips has agreed yesterday to stop selling ALL machines in the US as part of a safety lawsuit.
2.  In November the FDA issued a safety warning for the Dreamstation 2 that is is more likely than other machines to overheat and catch fire.   

I called my DME immediately.  They seemed totally unconcerned, saying they would have to hear this from Phillips, but said they would send an e-mail to their manager.  I do not want this in my house.  Am I screwed because I accepted it yesterday?  It looks like the Resmed Airsense 10 is the machine of choice here--is there a newer model number that people like?

I am posting my initial sleep study and my 2nd sleep study with a CPAP machine so they might help someone help me with a machine recommendation.  Thank you very much for any and all help!!

INITIAL TEST:

SLEEP ARCHITECTURE & STAGING (central, occipital, frontal EEG,
bilateral EOG and digastric EMG):
Testing began at 11:20:01 PM and ended at 6:00:38 AM, for a total
recording time (TRT) of 400.6 minutes. The sleep period lasted
371.8 minutes and the total sleep time (TST) was 295.0 minutes of
which 116.6 (39.5%) was while supine. Sleep efficiency (TST÷TRT)
was 73.6%. The sleep latency (SL) was 28.8 minutes, and the
latency to the first occurrence of Stage REM was 218.0 minutes.
There were 1 Stage REM periods observed on this study night and
20 awakenings (i.e. transitions to wakefulness from any sleep
stage), and 113 total behavioral stage transitions. Wakefulness
after sleep onset (WASO) time was 76.8 minutes, while the time
spent is each sleep stage was 30.5 minutes Stage 1; 250.5 minutes
Stage N2; 8.5 minutes Stage N3; and 5.5 minutes for Stage REM.
The percentage of total sleep time in each stage was: 10.3% Stage
N1; 84.9% Stage N2; 2.9% Stage N3; and 1.9% Stage REM.

AROUSAL (central, occipital, frontal EEG, bilateral EOG and
digastric EMG):
Arousal indices are reported as # arousals per hour of sleep.
The patient experienced 182 arousals in total. The arousal index
was 37.0. Of these, 53 were identified as respiratory-related
arousals (respiratory arousal index 10.8), 62 were periodic limb
movement (PLM)-related arousals (PLM index 12.6), and 67 were
spontaneous (spontaneous arousal index 13.6).

RESPIRATORY (thorax and abdominal respiratory inductive
plethysmography, nasal-oral thermistor and nasal pressure):
Respiratory event indices are reported as # abnormal respiratory
events per hour of sleep. The patient experienced 7 apneas in
total of which 7 were identified as obstructive apneas, 0 were
mixed apneas, and 0 were central apneas. This resulted in an
apnea index (AI) of 1.4. The overall AI for central, mixed and
obstructive apnea were 0.0, 0.0, and 0.8, respectively. The
patient experienced 55 hypopneas in total, which resulted in a
hypopnea index (HI) of 11.2. The overall apnea-hypopnea index
(AHI) was 12.6. The AHI during REM sleep was 0.0. AHI by
body-position was as follows: supine AHI 15.4, right-side AHI
N/A, left-side AHI 10.8 and prone AHI N/A. There were 0
occurrences of Cheyne Stokes breathing, and 0 respiratory effort
related arousals (RERAs). The RERA index was 0.0. The
respiratory disturbance index (RDI) while supine was 15.44 while
when not supine the RDI was 10.76. The total RDI was 12.6.
Snoring was reported to be of mild to moderate intensity.

OXYHEMOGLOBIN SATURATION (SpO2):
Analysis of continuous SpO2 using beat by beat analysis showed a
maximum SpO2 value of 94.3% with a minimum oxygen saturation
during sleep of 90.0% and a mean value of 94.3% for the same
period. SpO2 was never below 90%.

CARDIAC (single lead EKG):
The average heart rate during sleep was 59.4 bpm, while the
highest heart rate for the same period was 76.0 bpm.

LIMB MOVEMENTS (right and left anterior tibialis EMG):
There were a total of 142 periodic limb movements (PLM) during
sleep, of which 57 were associated with arousal. This resulted
in a PLM index of 28.9 and a PLM arousal index of 11.6.

INTERPRETATION:
1. The sleep efficiency is lower than expected for a night in the
sleep laboratory. Prolonged latency to sleep onset. Increased
wakefullness after sleep onset time. Respiratory arousal index is
increased. REM sleep relative to total sleep time is markedly
reduced. Supine sleep accounts for 39.5% (116.6 minutes) of the
total sleep time.
2. Physiologic atonia of the digastric EMG in REM was
appreciated.
3. The AHI and RDI are 12.6 and 12.6, respectively. The
polysomnography is diagnostic mild obstructive sleep apnea (ICD
10 G47.33).
4. SpO2 was never below 90%.
5. Electrocardiogram data showed normal sinus rhythm
6. PLM index was 28.9 and PLM arousal index was 11.6. PLM index
is abnormal. While elevated, the arousal frequency from PLM may
not necessarily led to symptoms.

TEST 2 with CPAP

SLEEP ARCHITECTURE & STAGING (central, occipital, frontal EEG,
EOG and digastric EMG):
Testing began at 11:36:01 PM and ended at 5:56:15 AM, for a total
recording time (TRT) of 380.2 minutes. The sleep period lasted
379.8 minutes and the total sleep time (TST) was 370.5 minutes,
which resulted in a sleep efficiency (TST÷TRT) of 97.4%. The
sleep latency was 0.5 minutes, and the latency to the first
occurrence of Stage REM was 182.0 minutes. There were 3 Stage
REM periods observed on this study nigh and 10 awakenings (i.e.
transitions to wakefulness from any sleep stage), and 69 total
behavioral stage transitions. Wakefulness after sleep onset
(WASO) time was 9.3 minutes, while the time spent is each sleep
stage was 14.5 minutes Stage 1; 261.0 minutes Stage N2; 52.5
minutes Stage N3; and 42.5 minutes for Stage REM. The percentage
of Total Sleep Time in each stage was: 3.9% Stage N1; 70.4% Stage
N2; 14.2% Stage N3; and 11.5% Stage REM.

AROUSAL (central, occipital, frontal EEG, EOG and digastric EMG):

The patient experienced a total of 43 arousals for an arousal
index of 7.0 arousals/hr. Of these, 6 were identified as
respiratory-related arousals (1.0 /hr.), 0 were PLM-related
arousals (0.0 /hr.), and 37 were spontaneous (6.0 /hr.).

RESPIRATORY (thorax & abdominal respiratory inductive
plethysmography, PAP derived flow):
Continuous positive airway pressure (CPAP) was applied from 4
cmH2O to 8 cmH2O. The treatment interval table that follows shows
the relationship between treatment setting and respiratory
outcomes. Supine REM sleep was seen at the therapeutic PAP
during this study. AHI and RDI less than 5 in an interval
containing supine REM sleep was achieved at CPAP 7 cmH2O and it
was the therapeutic PAP during this study. Residual snoring was
reported at lower pressures.

OXIMETRY (SpO2):
Analysis of continuous oxygen saturations showed a mean SpO2
value of 94.9% and a minimum SpO2 during sleep of 83.0%. SpO2 ?
88% occurred in 6.3 minutes of the total sleep time.

CARDIAC (EKG):
Analysis of electrocardiogram activity showed the highest heart
rate during the recording was 88.0 beats per minute. The average
heart rate during sleep was 65.0 bpm,

LIMB MOVEMENTS (right and left anterior tibialis EMG):
There were a total of 21 periodic limb movements (PLM) during
sleep, of which 0 were associated with arousal. This resulted in
a PLM index of 3.4 and a PLM arousal index of 0.0.

INTERPRETATION:
1. Sleep efficiency is within normal limits for a night in the
sleep laboratory. Sleep latency is within normal limits.
Wakefullness after sleep onset time is within normal limits.
Arousal frequency is within normal limits for a night in the
sleep laboratory. REM sleep time relative to total sleep time is
mildly reduced.
2. Physiologic atonia of the digastric EMG in REM was
appreciated.
3. OSA (ICD 10 - G47.33) responsive to positive airway pressure
therapy.
4. American Academy of Sleep Medicine criteria for optimal CPAP
titration was achieved at 7 cmH2O.
5. PAP therapy was delivered via a Resmed AirFit P-10, Small
interface. A chin strap was added at CPAP 7 cmH2O due to mouth
opening and air leak.
6. The average heart rate during sleep was 65.0 bpm, Cardiac rate
during sleep is normal.
7. PLM index was 3.4 and PLM arousal index was 0.0. PLM index is
normal. PLM arousal frequency is within normal limits.

[Sleeprider]

Decline the machine. Return it to them an insist on a Resmed Airsense 10 or 11 Autoset. Find a different DME because this one is trying to stick you with a device even they can't sell. The will get reimbursed by Philips for the unsalable device, but if you keep it, you're stuck. If you want to go out of pocket, Supplier #1 is selling the Resmed Airsense 10 Autoset card to cloud for $399. That might be less than your DME hits you for deductibles and copay. Absolutely the best auto CPAP on the market with full data and better features than the Philips.

[Montacute]

Thanks so much.  Can I call them and say I decline the machine even though I took it yesterday, being totally ignorant?

[Montacute]

On the phone with them now.  Told them they need to come get this fire hazard out of my house before I write a complaint to the state health department.  I am really aggravated they gave this to me.

[Sleeprider]

Yes, and explain why you decline it. Request a Resmed Airsense 10/11 Autoset. If they do not cooperate, then explain you will need to work with a different DME and discuss this matter with your insurance. Placing a call to your insurer to see if they will back you up in declining this machine, may be a good idea. Basically, they sold you a machine that Philips withdrew from the market on January 25.

[Montacute]

Good advice on calling insurance too, thanks.  Will do that now.  I just got off the phone with DME.  I asked when they are going to come get this fire hazard out of my house.  They did keep saying that they had no notice of a "recall".  I said Phillips stopping sales in the US, having a data breach, and the FDA issuing a safety warning are much worse than a "recall."  I told them they should make it their business to check FDA warnings for what they sell.  I invited them to check the news for the sale stoppage.  I am really aggravated they tried to give me this unit.    Anyway, they claim a coordinater will call me back to discuss this.  I again said I am not keeping this fire hazard and will make a complaint with the Florida department of health if I have to.   So, I'll update when I have a response.  No one with any authority is ever available when I call this place.  Their lunches must be from 11 to 5. 
I wonder how many others they are trying to stick with this machine.

[Sleeprider]

I want to add, we are in uncharted territory here. We have never dealt with a major health care equipment manufacturer withdrawing from the market under the terms of a Consent Decree. At least it is new to me. I don't know that any policy for this circumstance exists at either the DME or your insurance company, so you may have to escalate to management or corporate level to bet a decision. I don't personally know the legal obligations of your DME in this circumstance, but I think I know what is the "right thing to do". Make some noise. Returning the machine at least preserves your rights, and gives the DME the burden of returning it to Philips.

[Sleeprider]

Montecute, this thread deals with the discontinuation of sales and devices in the U.S. There are lots of links here to share with your DME including the Consent Decree filed with the Security Exchange Commission. https://www.apneaboard.com/forums/Thread...#pid500380

[Deborah K.]

I assume your DME is local since they brought the machine to you.  If I were you I'd take the machine and anything else you got from them to their office and insist that they take it back then and there.

[Montacute]

Thank you everyone.  I will bring the unit back in person tomorrow--no car today.  That is excellent advice Deborah.  Guess what?  No return calls.   In the meantime I let insurance know, and I have filed complaints with 1.  The FDA  2.  The FL Health Department  3.  The FL Office of Insurance Regulation 
Here is a copy of the complaint I wrote, with citations, in case it helps someone else.  Sleep rider I will check the thread you sent for the consent decree for further complaints and a letter to Integrated.  Thanks.

Oh, I see I cannot post links with less than 4 posts, so will post my complaint separately.

---

Here is the complaint, but I still can't post the links. Oh well. I will X them out.

The medical device supplier my insurance told me I must use, Integrated Home Health Care at 3700 Commerce Pkwy, Miramar, FL 33025, delivered a Philips Dreamstation 2 to me on January 30, 2024. I was not given a choice of CPAP machines. This unit was just delivered to me. In researching the unit, I found that:

1. The FDA had issued a safety warning on November 28, 2023 that the unit could overheat, causing burns, smoke or even fire. The FDA's advice was to keep the unit away from fabric and carpet that could catch fire. This is not practical as I need to keep the unit next to my bed during the night.
XXXXXXXXXX
2. On January 25, 2024 after a long history of safety recalls of various CPAP machines, as part of a consent decree Philips agreed to stop selling ALL CPAP units in the United States. The foam inside the machines released dangerous carcinogens.
XXXXXXXXXX

3. Independent testing in 2023 shows the Dreamstation 2 foam still releases dangerous carcinogens, including formaldehyde. No doubt this was part of why Philips had to stop selling ALL CPAP machines in the United States.
XXXXXXXXX

Integrated Home Health Care acted negligently, if not fraudulently, by forcing this CPAP device on me without any disclosure of the serious issues. Furthermore, they should not have given me a unit the manufacturer was BANNED from selling in the United States due to ongoing safety concerns. No one of sound mind would chose to buy a new Philips machine given these serious safety issues and indeed could not in the United States after Philips stopped selling them. Integrated Home Health Care knew or should have known about these issues. Upon calling them, all they will say is that Philips has not informed them of any "recall" with the Dreamstation 2. A complete stoppage of sales is much, much more serious than a recall. I believe they were quickly trying to unload this worthless product on me. I hope there can be some sanction against Integrated Home Health Care for doing this. I am still waiting for a return call after calling them twice to say I want this dangerous, carcinogen releasing fire hazard out of my home and want a ResMed CPAP machine.
I wonder how many more people Integrated Home Health Care will try to offload these unsafe machines on, because they are not sellable. I hope you can stop them.