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

[btreger]

I'm not quite sure what your point is here.  Are you saying it's going to be difficult to do the repair on that many different model numbers? 

As far as I can tell, most models of the DS1 machines are the same hardware with different software and/or cosmetic changes such as logos and colors.  

Yes, only 4 of the 18 recalled products are DreamStations. The only common feature is that they all used the same foam.

Continue life-sustaining ventilation prescribed therapy

Continuous Ventilator (3)

Continuous Ventilator, Minimum Ventilatory Support, Facility Use (2)

Continuous Ventilator, Non-life Supporting (2)

CPAP and BiLevel PAP Devices

Continuous Ventilator, Minimum Ventilatory Support, Facility Use (1)

Continuous Ventilator, Non-life Supporting (5)

Non-continuous Ventilator (5)

A number of these devices are for hospital use only, and others are for medical use only. So if you look at each device, I would say getting to the foam would require different methods, procedures, and tools. 

Here are the recalled devices;

Sleep and respiratory care update | Philips

[archangle]

The first three or four motor/foam swaps of a DS1 or PRS1 might take some thought, but after that, it's mostly going to be something you can do in your sleep.  I'm pretty sure the motor and foam are going to be pretty standard in each DS1.  Similar for PRS1.  Then hook up the test connection for the software and the hardware connection and run the test.

As for software differences, that will presumably be handled by the uber-secret authorized shop-only repair/maintenance software.   i.e. feed it the model number and it knows what to do.  Hook back up to Philips on the internet if it needs an update.   I've seen the instructions for older versions of such software. 

Probably a few glitches on the first 5 or 10 machines you do, then it's mostly gravy.  

I suspect any repair tech with the skills to change the motor before Foamgate could do it pretty easily.  

As for training, I bet that you could put an experienced tech and a newbie tech in a room together and the noob could do replacements on his own within a day with the experienced tech working nearby checking and lending a hand as needed.  You could add one tech per day and quickly have a team of 6 capable of doing JUST the Foamgate repairs if you have the parts.

Anything the first line tech plus crew can't handle could be sent or saved for a second level tech. 

Now, if Philips is wanting to do some other things in addition to Foamgate upgrades, that's another thing.

[btreger]

RE: >above<

I would also add that you would need extensive working knowledge of the operations, setup, and configuration of each machine. In my opinion, most would require a trained technician to do the job correctly.

[WakeUpTime]

Philips, in their most optimistic guess, is suggesting they'll be able to repair/replace 80,000 devices per week by 2022.  Whether it's a repair or replacement, there's either foam and/or device setup involved.  If, on average, they can repair/replace one every 15 minutes, if my math is correct, they'll need 500 technicians (?) of their own or with 3rd party companies.  (Assuming 40 hour weeks and repairing/replacing 4/hour.)  Whatever the numbers are, this is a major multi-country procedure that is filled with complexities.

[archangle]

Yes, only 4 of the 18 recalled products are DreamStations. The only common feature is that they all used the same foam.

---

A number of these devices are for hospital use only, and others are for medical use only. So if you look at each device, I would say getting to the foam would require different methods, procedures, and tools. 

Here are the recalled devices;

Sleep and respiratory care update | Philips

Probably 95% of the machines in the USA will be the Dreamstation hardware or PRS1 hardware in two flavors.  That's probably only 2 basic mechanical hardware replacement processes, with maybe some minor variations between the two PRS1 types (50 or 60).   I don't know how many DreamStation Go models are out there, but that may be another species to deal with.

I don't see it as being that difficult if you have the parts and the software.  Undo x screws, push here with a screwdriver to release a latch, unplug/disconnect these hoses and connectors.  Check this and that.   Replace certain parts.  Blow the dust out and rinse some things.  I don't know if they'll have the techs doing anything like removing glued-in foam, but I suspect they'd simply replace what the foam is glued to.  Reassemble, plug in the software and a hardware test rig and test it.  Learn 3 hardware types and you get the vast majority of machines needing replacement.

I've disassembled a PRS1 and reassembled it correctly with no training.  I'm a tech smart guy, but not a repair guy.  Give me the parts, the instructions, and I could do the mechanical part of the first level Foamgate tech.  I might need phone support on the first few. I think they require no mechanical tools more specialized than a Torx screwdriver, but if so, I'd need that.  Give me the software, any special plugs or test tools, and a computer, and I could do that, too. 

I'm sure Philips will do more paperwork and bureaucracy than that, but actual task isn't that difficult, as long as you have the replacement parts.

I'm not familiar with the A-series, but they look like the same hardware for 4 models.  Don't seem to be in the US, may be mostly for professional use. 

The Trilogy and Garbin plus vents are mostly professional use, but there are some home users.  Probably with frequent high-dollar maintenance on a regular schedule already.  Those might be 3 separate repair processes.  Probably a lot fewer of those machines than DS1/PRS1.

[archangle]

RE: >above<

I would also add that you would need extensive working knowledge of the operations, setup, and configuration of each machine. In my opinion, most would require a trained technician to do the job correctly.

I took apart a PRS1 machine and reassembled it correctly with no instructions. 

It's not that hard. There's no magic in the mechanics, just screws, wires, circuit boards, a motor, plastic mechanical parts, foam, and sensors.   You don't mess with the sensors, you just connect the wires and hoses correctly and the software does the rest.

I'm tech smart, but not a repair technician type.  With parts, equipment, and 2 hours of training, I could be a top notch first level Foamgate repair performer on an assembly line for PRS1 machines.   The next day, with 2 hours of training, I could probably be a DS1 Foamgate fix guy.  Another day would probably add any of the other individual models. 

Note that I wouldn't be a generalized diagnostic CPAP repairman, just a guy who could do the Foamgate fix to an otherwise OK machine and check the machine out well enough to know whether to hand it to a second level tech.

[btreger]

I've disassembled a PRS1 and reassembled it correctly with no training.  I'm a tech smart guy, but not a repair guy.  Give me the parts, the instructions, and I could do the mechanical part of the first level Foamgate tech. 

We are talking about very serious issues. Millions of people around the world are affected. You keep using yourself as an example, you are only one person, with only one set of skills.

In your Post #1252, you used these words:

might take some thought
I'm pretty sure
Probably a few glitches
I suspect 
I bet that
I'm a tech-smart guy

We are not talking about replacing a battery in a cell phone. We are talking about highly complex machines designed to sustain human life.

So, no matter how sharp you think you are, in the bigger picture of the seriousness of this recall. we would all like to know that our lives are in the hands of professionals that understand what failure really means.

[kbeast01]

only just found out about this today. had my dreamstation since march 2020. rang respironics to get a replacement headband and they told me to visit a web link.

now im not even sure if i should use it tonight. gp surgery was a joke and my specialist isnt in today.

since i started using it if i dont use it i feel like trash

[WakeUpTime]

"Millions stuck in nightmarish recalls of sleep apnea breathing devices"
August 23, 2021

But consumers complain that they’re getting poor and too little information about their health options until the device maker more fully addresses the products’ problems.  Doctors are trying to sort out with individuals the seriousness of their sleep disorders, the risks of discontinuing for even short periods the treatment with the devices, and possible arrangements to secure replacements, notably from a Royal Philips competitor. That firm says it is trying to assist patients, but [Philips] has detected significant price increases in its own product, as consumers scramble to buy up substitute devices.

Patients are growing frustrated and angry that Royal Philips, aside from accepting online registration of potentially problem machines, has not explained in detail to the FDA or customers how or how soon devices will be fixed or replaced. The company says it is working overtime to increase supplies and [Philips] is trying to triage complaints, so patients in greatest need get help quickly.

The class-action law suits against Philips continue to pile on each week.  On August 20th, a series of 4 "Summons Issued" against Philips were filed in the State of Georgia on Contract Product Liability, and Fraud (ROGERS et al v. KONINKLIJKE PHILIPS).

[Sea Papper]

If, on average, they can repair/replace one every 15 minutes, if my math is correct, they'll need 500 technicians (?) of their own or with 3rd party companies.

Assuming a 24/7 repair operation. 80,000 units/week is 11,428/day is 476/hour. At 4 repairs per hour per tech it comes out to 119 technicians working around the clock. Assuming 3 shifts at 8 hours they need 357 technicians. Mamma always said it was best to just do things the right way from the start.

CEO Frans van Houten said “To be clear, we do not have data at this point such as preclinical or clinical study results indicating that exposure to the particulates or emitted chemicals related to the sound abatement foam will lead to disease, while at this point, we cannot exclude it either,” 


Philips/Respironics - stick a fork in it?  The Respironics regulatory management is obviously incompetent, ignorant, unethical, and amoral. Knowingly shipping a medical device that forces toxic particles into a patient's lungs, under pressure, is downright evil. Respironics got nothing on Irwin Mainway. "Hey kid, be careful, it's a bag o' glass" These products were obviously illegally labelled as medical devices. How can the "Substantially Equivalent" claims in the 510(k)s be accurate if they used different materials in the air circuit? About time the FDA actually read and audited the DS2 510(K). 

No new sales for up to 12 months. Millions of dollars in repair labor. Many millions of dollars in material. Many millions of dollars in legal damages. Mucho millions of dollars in lost sales. Clearly FALSE statements made to investors. Saving a few pennies by using the "cheap" material. Well PRICELESS! 


Recall may have knocked Philips out of sleep devices market for a year? ResMed just picked up more than $1B in sales by simply doing things right...just like Mamma said.