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

[WakeUpTime]

"Children still waiting for defective breathing machines to be replaced"
Nearly 90 young patients affected more than a year after safety recall
The Times |  July 16, 2022
https://www.thetimes.co.uk/article/4197a...ab4be53761

Dozens of children are waiting for their defective breathing machines to be replaced more than a year after a worldwide recall was issued...  "The replacement of the device in children is more complex than in adult services as many of these children require an inpatient stay to replace the device.”

"Sleep Relief: New Sleep-Aid Devices Replacing Machines Recalled for Risks"
Millions of CPAP and other sleep-aid devices were recalled more than a year ago
NBC Chicago  |  July 18, 2022
https://www.nbcchicago.com/consumer/slee...s/2884465/

Edward said he had used his Philips CPAP machine for three years, not giving it a second thought. That is until Philips Respironics announced a voluntary recall on June 30, 2021, of some 15 million CPAP, Bi-PAP, and ventilator devices.  The devices in question contain a noise-canceling foam – now known to be carcinogenic – that can break down and be inhaled by the patients using them.  

NBC 5 Responds has been covering the recall since it was first announced, including reports by the Food and Drug Administration that suggest the company may have known about the problem inside the device years prior to acting on it, and announcing the recall.  

Then, last month, some sobering numbers arrived: the FDA said it has received more than 21,000 reports of injuries, and more than a hundred reports of deaths potentially tied to the recalled devices.  A spokesperson for the FDA acknowledges the agency hasn’t independently verified each of those reports.  Philips said it’s taking those cases seriously and is thoroughly investigating each report.

The company’s CEO also told shareholders in a recent call that it was served subpoenas by the U.S. Department of Justice, as part of an ongoing investigation into the Respironics recall.  But with so many devices impacted across the globe, Philips initially said it would take up to a year to repair or replace them all.  
Philips told NBC 5 Responds that it has shipped out 1.2 million replacement devices, and has produced a total of 2.7 million devices so far.

Based on the FDA’s total of 15 million devices impacted, that would account for only seven percent replaced and shipped out worldwide.

[WakeUpTime]

After more than one year, I finally received a response from Philips regarding a replacement for one of my two recalled Philips devices.  They're asking for my doctor's details for an updated prescription along with additional personal details such as date-of-birth.  The service phone number seems to be an anonymous local phone number out of Boston, MA, though that could be used by a temporary Philips contracted telemarketing agency.  Strange that they won't accept a prescription copy sent directly by me.  Instead, more delays and possible added costs for me, as my prescription is not recent.

Hello <name>,

I am pleased to inform you that we are currently working on your new remediated device to replace your current recalled device, XXXXXXXXXXX, which was recalled on June 14, 2021. Before your new device can ship, we need to contact your physician to obtain a current prescription.  This will ensure that your new remediated device is ready for your use upon arrival. We also need you to verify your legal name (including the spelling), date of birth and your shipping address so that we can ship your replacement to you.

You can provide all the requested information by simply responding to this email or by calling us directly at 1-857-758-7090
Information Needed:
• Physician Name
• Physician Phone Number
• Legal name (Please check spelling)
• Date of Birth
• Shipping Address

Once this information is received, our team will contact your doctor to obtain your current prescription with settings.

[btreger]

  They're asking for my doctor's details for an updated prescription along with additional personal details such as date-of-birth.  

Hi WakeUpTime

I would also be suspicious of this e-mail. Yesterday I went to what is referred to as my ( sleep doctor ). He is a Pulmonologist and would have no idea how to set up a CPAP device. He relies on my DME to do that. 

I brought a printout of OSCAR and a detailed list of everything I would need to upgrade to a AirSence 11 Autoset. He took a sheet of office stationery signed it and requested the DME to order everything listed and attached my document. He did know how to read OSCAR and liked my results.

Good luck............

[SuperSleeper]

Hello <name>,

I am pleased to inform you that we are currently working on your new remediated device to replace your current recalled device, XXXXXXXXXXX, which was recalled on June 14, 2021. Before your new device can ship, we need to contact your physician to obtain a current prescription.  This will ensure that your new remediated device is ready for your use upon arrival. We also need you to verify your legal name (including the spelling), date of birth and your shipping address so that we can ship your replacement to you.

You can provide all the requested information by simply responding to this email or by calling us directly at 1-857-758-7090
Information Needed:
• Physician Name
• Physician Phone Number
• Legal name (Please check spelling)
• Date of Birth
• Shipping Address

Once this information is received, our team will contact your doctor to obtain your current prescription with settings.

Hmm... why would Philips be requesting your personal info like this - especially your birthday?  The fact that you have a recalled machine proves that you already had a script for it.

They're going to call the doctors of thousands and thousands of patients to get the script & settings?  Not believable.  Too much work and potential for non-responsiveness.

I'd question where this email came from - what was the email address source?

If legit, it seems like it's simply one more stumbling block Philips is putting up so that they won't have to send out as many machines-- because "Your physician did not confirm your prescription when contacted".    No doctor is going to give up prescription info by someone simply calling them and requesting it for a specific patient, or via email request.  I'd think that would be a violation of patient privacy.

And, what about patients whose doctor is retired now?  That's the case with my original prescription, plus that was issued several years ago.  What new doctor is going to send out an 18-year old script to Philips?  So we have to get a new sleep study for a new script in order to qualify for a recalled device now?

Highly suspicious of this.  

[WakeUpTime]

I'd question where this email came from - what was the email address source?

My initial instict suggested that the Philips (or Philips 3rd party) Recall database had been hacked and it was phishing expedition for identity theft.  However, the source e-mail is:  "recallprescriptions@philips.com".

Knowing my doctor's office, it would be one week before they responded, after it got shuffled around.  It's not something they would quickly respond to.  They would then check the authenticity of it and Philips (or their 3rd party telemarketing company) wouldn't be able to verify very much beyond the machine and my basic details.  

My doctor has at least 3 different machine prescriptions on-file and he admits the last one (a result of a poorly done overnight sleep test) wasn't accurate.  He wouldn't know which prescription to write/forward.  As a result, he might order another sleep test before providing a new prescription - unlikely though.  He has no idea which machine I'm using.  They'd of course end up contacting me before releasing anything.  They might even ask me to provide them with a signed 'release authorization form' of some kind - or to setup an onsite medical visit.  

Like many other ApneaBoard members, I too have since purchased a ResMed replacement.  However, I feel badly for those who are still using their Recalled device, as there may be many who will have to go through additional steps (and time) before receiving a fix/replacement.

Incredible.  Perhaps this is Philips' response to those who never provided them much of anything in DreamMapper and purchased their devices from online DMEs.

[WakeUpTime]

Not surprisingly, this Philips Recall Thread, initiated by SleepRider on May 23, 2021, has today become the most viewed thread ever (within the 'normal' threads section) in ApneaBoard's history, with almost 209,000 views to date - and we're only part way through the Philips Recall.

[StratCat48]

WakeUpTime......

"Like many other ApneaBoard members, I too have since purchased a ResMed replacement.  However, I feel badly for those who are still using their Recalled device, as there may be many who will have to go through additional steps (and time) before receiving a fix/replacement.

Incredible.  Perhaps this is Philips' response to those who never provided them much of anything in DreamMapper and purchased their devices from online DMEs."

This is pretty much exactly correct. If the machine was not acquired through a 'real' DME, but rather an online supplier or a private sale, Philips in most cases has not been able to confirm that the person claiming a replacement actually is the rightful owner and has been prescribed the machine, thus they need/require the information you were asked to provide. I had gotten my original Dream Station through a 'real' brick and mortar DME who registered my machine with Philips when I received it. When I registered for the replacement Philips got all the information needed, including the settings from my DME. The settings were uploaded to my new DS2 when I powered it up and my DreamMapper account was updated to reflect the the new DS2. My DME had all the info, such as the serial number on the new machine in their records (likely from Care Orchestrator). I got the DS2 in about 4 months (registered 6/30/21, replacement 10/13/21) after I registered the DS1.

I don't believe Philips will replace a machine unless they can verify/prove you actually have/own a machine to replace and that you have a prescription. If one was patient enough, I think a trial and error registration serial number could be entered that would be accepted as valid for a machine that wasn't owned by the prospective claimant. Philips probably wants to avoid giving out 'free' replacements.

[WakeUpTime]

<< above >>

After responding to Philips' e-mail, I received a very lengthy (automated) e-mail reply from Philips.  Among other things, it mentioned that if all our details in the Recall Registration Database don't precisely match those on-file from initial device registrations at Philips, they will go additional steps to verify everything with the prescribing doctor.  

My DreamStation was registered several years ago, and I have a System One that was registered more than 10 years ago.  My address and phone numbers have changed since both product warranty registrations took place.  My online DMEs, like many others, are indeed authorized Philips DMEs - or they are attached/owned by one - so I'm somewhat confident that they provided my purchase details for initial warranty registrations.

There must be so many others who have also provided slightly different details in their Recall Registration that don't match their initial Philips Registration (from the forwarded details from the DME).  Addresses, phone numbers, and even last names may have changed for a significant number of people. 

There were also many who purchased their device second-hand.  Will Philips be allowed to simply ignore those faulty device owners and let the faulty devices remain unfixed?  It'll be interesting to watch Philips proceed through these more challenging phases of their Recall, from their perspective.

Now that Philips is moving on to these next phases of the Recall, given the above, it will be impossible for Philips to meet their target of satisfying 90% of Recalled owners by the end of this year.  However, no doubt Philips will have many excuses for not doing so (owner verifications, prescription provisions, labor shortages, supply chain issues, etc.).  They're ultimately going to miss their target significantly.

[btreger]

After responding to Philips' e-mail, I received a very lengthy (automated) e-mail reply from Philips.  Among other things, it mentioned that if all our details in the Recall Registration Database don't precisely match those on-file from initial device registrations at Philips, they will go additional steps to verify everything with the prescribing doctor.  

I would have to agree with SuperSleeper.  

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. 

I think the real reason you are being jerked around is that somebody at Philips has read some of your posts and this is their way of getting back at you.

You would think that by now we would have seen similar e-mails being posted but as far as I know, you are the first:

Congrats

[SuperSleeper]

They have no way to link WakeUpTime to his real name or email address.  I doubt this email is Philips spending time on some sort of personal vendetta against someone who posts here.