Firstly, I apologise for the length of this post, but I will try to add as much info/context as necessary.
Secondly, I apologise to anyone who has already read this from me in another thread, it was just pointed out by a fellow forum member that I should post this in it's own thread as my question was included inside a mask cleaning thread that may not draw much attention.
The "too long didn't read" summary of my question is as follows:
My mother is currently using a Philips Dreamstation BiPAP AVAPS machine (manufactured in the USA in 2019) that she has on loan from a local hospital to treat previously undiagnosed severe sleep aponea and obesity hypoventilation syndrome.
She has been using this machine for approx. 4 months now and it wasn't until late last week that a fellow forum member noticed me mentioning the machine in another thread and advised me of the recall and issues with this machine.
I contacted the hospital and they were not aware of the recall and have since checked the machine serial number, realised it was affected and have registered the device and initiated the replacement process, but this could take some time.
Since finding out the news about the recall and possible health issues caused by the breaking down of the foam etc. in these machines both my mother and I have become extremely worried and anxious about using it, if it wasn't so important to her health she would stop using it right now, but due to how severe her condition is we don't feel comfortable ceasing use of it until we receive a replacement machine (will explain more further on about her condition).
Now for the more in-depth details for those that wish to know:
Back in June last year my mother who is 69 years old was involved in a serious car accident which caused her some horrific leg injuries requiring many surgeries and quite some time in the ICU, 10 days of which were spent on a ventilator.
In total, she spent over 6 months in hospital before finally completing her rehab and coming home.
Along with her severe leg injuries, she also suffered a bruised lung, fractured C7 vertebrae in her spine and It was also pointed out while she was in ICU that the accident caused damage to her diaphragm which was causing her liver to push higher than it should, putting pressure on her lower lungs and therefore she was instructed to sleep in a slightly elevated position.
After initially making it out of ICU and beginning her recovery in the regular hospital wards she started having issues with respiratory failure, requiring re-admission to ICU an additional 3 times (including emergency helicopter flights etc. back to the major hospital that has the ICU unit).
Each of the 3 times in the days/weeks leading up to her respiratory failure she would experience hypoxemia, barely having oxygen levels around 86% during the day and waking up of a morning with blue fingertips and blue lips etc. and each time she recorded extremely high levels of Co2 in her blood (during the most recent ICU visit her Co2 level was up to 114, which one of the ICU nurses said was the highest she has ever seen).
Each of the 3 times in ICU they treated her with a BiPAP machine and after 4 to 5 days her Co2 levels returned to a safe level and she was released back to the regular hospital environment to continue her recovery and rehab from the car accident, however we were advised she would always have a higher Co2 level than a regular person (I am guessing this is chronic hypercapnia?).
During the time of these 3 respiratory failure events (which would happen usually 2 to 4 weeks apart after returning from ICU), our local hospital organised an in hospital sleep test for her.
Unfortunately, due to her severe leg injuries, getting her to a proper sleep centre for a proper in-depth sleep test was not possible, so the hospital used a kit from a local pharmacy to conduct the test.
The test showed that she had severe sleep disordered breathing and the doctor at the hospital said it was the worst reading he had ever seen from a sleep test, these are some of the results:
During her hospital stay, the doctor also had an echo-cardiogram carried out on her heart as a result of her having a lot of fluid retention and as a result of that it was mentioned to us that she has some heart failure as a result of the bottom of her heart not relaxing enough as it should, but we were advised that could fix itself once she recovers and becomes active again.Test device: Philips Alice NightOne
Monitoring Time: 660.7 mins
Sleep time: 603.2 mins
REI (A+H): 48.2
ODI (>3% desat/hr): 48.5
Spo2:
Wake: 73%
Min: 53%
Max: 82%
Mean: 69%
Duration / % time where Spo2 <90%: 654.3mins (99%)
Duration / %time where Spo2 <80%: 639.9mins (96.9%)
CAI: 0.1 (3.89% of REI)
Respiratory Events:
Obstructive Apnoeas: 43 Total Events, mean duration: 19.4 sec, max duration: 64.0 sec
Hypopnoeas: 441 Total Events, mean duration: 18.3 sec, max duration: 95.5 sec
RERAs: 55 Total Events, mean duration: 21.6 sec, max duration: 50.0 sec
Central Aponeas: 1 Total Events, mean duration: 18.0 sec, max duration: 18.0 sec
Mixed Aponeas: No Events
Sleep time in position: 603.20
REI in position (incl RERAs): 53.81
Physicians impression: The data represents severe sleep disordered breathing with severe hypoxemia with severe obstructive sleep aponea. APAP may be inadequate and should not be deployed unless specifically prescribed and supervised by a physician. Urgent sleep physician review mandatory.
Along with all this, we were advised that she likely has COPD and possible Emphysema which were previously undiagnosed before her accident (She was previously a long time smoker of approx. 40 years, giving up approx. 1 year ago), she has been placed on a long acting daily puffer to treat this.
Now that you have some history, I will get to the crux of my question:
My mother was given the loan Philips Dreamstation BiPAP AVAPS machine from the hospital after her 3rd respiratory failure ICU visit to treat her severe sleep aponea and obesity hypoventilation syndrome and provide her with ventilation to prevent Co2 from building up to dangerous levels in her blood.
So far it has been working amazingly for her, she has been using it for the past approx. 4 months and if I test her Spo2 levels with a pulse oximeter during the night it is always in the low to mid 90s, almost normal levels which is amazing compared to what it was without the machine.
We have also been able to tell the incredible difference it has made to her in daily life, no more slurry speech or blue lips/fingers, her daily oxygen saturations are usually always 90-93% now, compared to being in the mid 80s often prior to getting the machine.
The issue is, we have just recently discovered that her loan machine is one of the models that were recalled back in 2021, we have only just been made aware of the recall recently by another forum member, both my mother and I and the hospital staff had no idea about it.
As I mentioned at the start of the post, after informing the hospital staff about the recall they have now registered the device and started the process to have it replaced, but that could take quite some time.
So why not just use a script to get another machine for her now you ask? Well her situation has made that difficult...
Since these sleep issues were previously undiagnosed and only diagnosed while hospitalised and due to the injuries sustained in her car accident, she hasn't been able to get a proper diagnosis for them yet, she was told she would need to follow up with a respiratory specialist once she became an outpatient and once that happens they would arrange for her to receive her own BiPAP machine (which will be a ResMed model we have been told).
Since she has only just made it out of hospital recently, she hasn't been able to see the respiratory specialist yet to receive proper lung function testing or attend a sleep clinic for a proper sleep test etc. and thus she doesn't actually have a script etc. for a machine, she only has the loan machine set-up for her by the hospital.
We have an appointment with a respiratory specialist late this month but that is still weeks away and both my mother and I are extremely worried and anxious about continuing to use this affected Philips machine until then, however we are also too afraid to stop using it since it is so vital for her health.
I have done some visual inspections and I have not noticed any black coloured particles in the water tray of her machine (a lot of regular looking dust particles, but no black particles that I have noticed) and upon inspecting the tubing and her mask I have not noticed any black particles either, however I have only known about the issue and paid attention to this for a couple of days.
What I did find was a lot of black dust-looking particles on the table behind her machine, but I really don't know if they are fragments of foam from the machine or just co-incidental regular dust.
I have also noticed some of these black dust-looking particles inside the humidifier tray of her machine (not as many as on the table), but again I am not sure if they are foam particles or just regular dust.
We clean her humidifier water tray, mask & mask tubing weekly using water and a fragrance-free soap, and I wipe down her mask daily with ResMed mask wipes, however we have never cleaned inside the humidifier compartment under or around the water tray, so the small black particles found in there may just be old dust.
We have never used an Ozone cleaner or UV cleaner on the device, however I cannot speak for those that had the machine before us since it is a loan device after all.
We live on the east coast of Australia and it has been extremely hot and humid here, which I understand is not good for the foam breakdown issue, but unfortunately that is unavoidable and her room is not air-conditioned.
Below is a picture of the black dust-like particles I found on the table behind her BiPAP machine:
As a test, I cleaned off the black particles from the table last night prior to her using the machine, then checked the area again this morning after a night's use, there did not seem to be any new particles in the area, which I take as a hopeful good sign.
One thing I have noticed (and have noticed for a long time) is that of a morning the remaining water in the water tray of the machine appears to have a thin film on-top of it, like a film you'd expect to see from a chemical or something, it can be difficult to see unless you have the light on it correctly but it is quite noticeable, it is not rainbow coloured like fuel or oil in water, it is just like a grey'ish splotchy looking film.
The prevalence of the film substance on the water is not overly consistent, it seems to mostly always be there after a night's use of the machine, but sometimes it appears worse than others, for example this morning it was not as bad as a couple of days ago.
The water we use in the humidifier water tray is bottled distilled water, and it looks perfectly clean before use, the film only appears on it after the machine has been used, but like I said it isn't super noticeable, at a quick glance you probably wouldn't see it unless you were specifically looking for it and have the light on it correctly, at which point it is clearly visible.
I have no idea if that film on the water is related to the foam breakdown issue these machines were recalled for, but it just something I have noted.
She does not have a HEPA filter in her room, nor does she have any device that could be emitting chemicals into the air, and we do not use aerosol sprays in her room.
We change the air filter on her machine every 2 weeks, it has looked clean from what I remember since we have been changing it, however I remember the original filter that came with the machine when we received it was quite black/dirty.
The advice I am looking for is basically how dangerous is it for my mother to keep using this recalled Philips BiPAP machine until we can source her a ResMed model? As I suspect to have hurdles to jump through to secure the ResMed model given her unique situation of not having official diagnosis of her conditions yet.
Both my mother and I are extremely worried about her continuous use of this recalled machine, but the worry of her not using a machine given how much she needs it is just as bad, I am going to phone her respiratory specialist on Monday and see if there is any chance of an earlier appointment for her, and failing that I will try to see if the hospital team can organise a ResMed machine for us to just buy and pay for outright ASAP.
We are also both extremely worried also about the past 4 months she has been using this machine and what damage may have been caused to her.
I am incredibly sorry for such a long post, and if you managed to make your way through the whole thing, sincerely thank you!
Any advice would be greatly appreciated, I have probably left out some valuable information but with such a long post there was so much to remember to type! Please let me know if you have any questions that may help your advice.
Thank you all.
