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

[Phaleronic]

I replaced my dreamstation autobipap airchamber with a non-foam one as I didn't want to wait for Phillips, I'm glad you finally received yours!

[btreger]

FDA:


Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication

Date Issued: August 29, 2022

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.

This recall is not associated with the PE-PUR foam issue impacting certain BiPAP machines recalled in June 2021, described in the Update: Certain Philips Respironics Ventilators, BiPAP Machines, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication. However, this new recall does apply to some of the devices recalled in June 2021.

Philips distributed 386 affected BiPAP machines in the U.S. between August 6, 2020, and September 1, 2021. On August 26, 2022, Philips sent affected customers, including Durable Medical Equipment (DME) suppliers, an Urgent Medical Device Recall letter. The models, some of which are intended for use only in clinical environments, are listed below; however, only machines with the serial numbers identified in the company’s Urgent Medical Device Recall letter are affected by this recall.

Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication | FDA

[SleeplessinPgh]

I registered my DS1 the first week of the recall.  FedEx dropped a new DS2 on my doorstep over the weekend.  No advance notice of any kind.  I tried it out and was pleasantly surprised.  It's smaller and quieter than the DS1.  My only complaint is the hot plastic smell. Today I soaked the humidifier tank and hose in Dawn & hot water, and left everything open to air out.  It should smell better tonight.

[TimaaaaaaaahRocks]

FDA:  Certain Philips Respironics BiPAP Machines Recalled Due to a Plastic Issue: FDA Safety Communication
...
The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers that Philips Respironics (Philips) recalled certain bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines that may contain a plastic contaminated with a non-compatible material. If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs). The plastic may also cause the machine to fail and stop working suddenly during use.
...

It's not a "non-compatible material", it is a "non-BIOcompatible material".

Doesn't the FDA require a biocompatibility assessment to ensure that all materials used in a medical device are safe, i.e. non-toxic?  

How does one get away with manufacturing, and shipping a device with a "non-BIOcompatible material"? 

[btreger]

MEDTECHDIVE

Philips settles government claim for $4.2M over military certification of portable patient monitors

Philips said on Tuesday it reached a $4.2 million settlement with the U.S. Department of Justice under the False Claims Act over its IntelliVue MP2 Mobile Patient Monitor.
 
The DOJ alleged that Philips sold the device to military customers after substituting key components of the device, without re-certifying it to ensure it was safe to use in aircraft.

Philips settles government claim for $4.2M over military certification of portable patient monitors | MedTech Dive

[Mark Douglas]

I received an email from globalintake-noreply@sedgwick.com 8/19/21, 16:31. under the heading

"CORRECTION - Update on your Philips registration"

I was forced to change email providers so it's possible my initial registration was earlier and I don't have that info.. I just now phoned the contact # and eventually was told they cannot match a DME to my claim. This is likely because I bought it gently used from a place NE of Cincinnati (don't recall if I can say who so for now I will not) but they are well known. I will contact the DME tomorrow and see if the DME can help.

I answered during the initial registration I did not use ozone to clean it and I suspect that got me pushed to the bottom of the pile. I answered the same today but asked for an addendum stating I am under treatment for serious whole body inflammation and I'm aware out-gassing from these machines can exacerbate inflammation.

If I learn anything useful I'll post again.

[WakeUpTime]

<< above >>

It'll be interesting to see how Philips deals with serial numbers that don't match the original purchaser.  Let's say the original DME forwarded the s/n (and owner details) at the time of purchase.  Regardless whether or not they did, that DME in 2021 likely also did a database dump of all those original Philips device owners to forward to Philips.  Some markets have some very small DMEs that might have an accounting system with serial numbers, and a customer contact database perhaps storing models without serial numbers.  They're unlikely to want to spend a few weeks cross matching those two databases, especially without compensation, to provide to Philips.
 
Since your system s/n might be seen as matching another (original) owner (personal or business), it'll likely be flagged as a conflict, requiring Philips (or their 3rd party contact database company) to obtain further details.  There's probably a flow chart that they'll use to determine whether or not those recalled devices will be replaced.
 
Those in that category (including my two recalled devices) will likely be waiting significantly longer, and may have to jump through more hoops (documents, updated DME details, etc.) to be verified and receive a replacement - if they ever receive one at all.  It's my guess that many won't as Philips will merely say, in the name of safety, athenticity, federal laws, etc., they couldn't update the user's faulty Philips device.
 
There are other complex categories too.  What if that original DME is no longer in business, or no longer selling Philips equipment?  What if that original sale became a return to the DME who later replaced that original owner's device with another model or brand?  What if there was an insurance replacement, or the sale went through another middle company?  These less-than-perfect (in the eyes of Philips) recalled device owners may not just need to wait a few more weeks.
 
Ideally, the FDA would have an ombudsman (mediator) to address those that aren't being sufficiently serviced by Philips for their faulty recalled device.  Ultimately, the rule should be, if I have a faulty recalled device in my possession, Philips should be forced to repair or replace it.  "Possiby, in 18-24 months, or perhaps never" shouldn't be entertained as an option from the manufacturer towards any current defective product owner.
 
If I have a Toyota with a faulty manufactured air bag, all I should need to do is drag it into the nearest dealer for replacement.  Realistically, I shouldn't even need to give my name, as the manufacturing defect has absolutely nothing to do with me personally.  It's a faulty designed part that's been proven to be unsafe and dangerous.  The dealer would replace the faulty designed unsafe part with a new part, update the s/n in manufacturer's database, and be done with the issue. 
 
Instead, Philips has pushed back against the victim whose only mistake was in choosing a medical device manufacturer that would ignore and downplay issues of basic heath and safety, instead putting the spotlight on the current user, the original DME, the current DME, the reseller, etc., to ensure that they meet Philips' strict extensive qualifications.  That's quite ironic indeed.  In doing so, Philips will be given substantially more time to satisfy that user (delays that it needs), and the option to completely erase a subset of recalled device registrants who only want to continue using their "safe" medically required device.  Indeed, it's likely that with a million or more owners awaiting replacements, Philips will declare that they've replaced all those who "qualify".  Recall completed.

For one of my recalled devices, Philips asked me significant additional personal details, including the name of my doctor and my current (not original) DME.  For that device, I personally (without insurance) purchased the product new from the Philips authorized DME.  As a result of a significantly postponed admission of a manufacturing design defect, I must defend myself and attest to the current active use of my medical device, and incur any additional expenses as required my doctor's office or DME for any additional time generating documentation to attest to my use and device settings.  Philips' additional requirements placed upon me (and likely others) seem quite extraordinary.
 
Philips has been granted far too much leeway in resolving their faulty recalled devices.  Please keep us updated on any progress.

[btreger]

MEDTECHDIVE

Philips settles government claim for $4.2M over military certification of portable patient monitors

Philips said on Tuesday it reached a $4.2 million settlement with the U.S. Department of Justice under the False Claims Act over its IntelliVue MP2 Mobile Patient Monitor..

Philips settles government claim for $4.2M over military certification of portable patient monitors | MedTech Dive

In a separate settlement, Philips must pay $24m for alleged kickbacks paid by the subsidiary formerly known as Respironics.

Philips To Pay $28M In Two Separate False Claims Act Settlements :: Medtech Insight (informa.com)

[ST Dog]

No doctor is going to give up prescription info by someone simply calling them and requesting it for a specific patient. I'd think that would be a violation of patient privacy. 

They do it all the time. I request a refill on a prescription and the pharmacy calls the doctor for a new Rx.

I also bought a new CPAP online. Gave them my doctor's contact info and they contacted the doctor for an updated Rx.

[ST Dog]

If I have a Toyota with a faulty manufactured air bag, all I should need to do is drag it into the nearest dealer for replacement.  Realistically, I shouldn't even need to give my name, as the manufacturing defect has absolutely nothing to do with me personally.  It's a faulty designed part that's been proven to be unsafe and dangerous.  The dealer would replace the faulty designed unsafe part with a new part, update the s/n in manufacturer's database, and be done with the issue. 

No government organization requires you have permission to purchase an automobile.
A license is only required to operate said vehicle on public streets, a 10yr old can drive a truck around on private property (ie. farm) all day long.

The FDA requires a doctor to state need and professionals are supposed to train you in the proper use.

I can take an automobile to dozens of repair shops, and even purchase parts to repair myself.

Good luck finding someone local authorized to repair a CPAP machine or getting parts.