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[News] RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(07-22-2022, 05:47 PM)StratCat48 Wrote: "The DS1 does not do BiLevel therapy."


Wasn't sure if it could or not. A couple online sellers webpages seemed to hint the DS1 was capable of either APAP or Bi-Level in one machine, but you are correct after I dug around a bit that the Bi-Level is a different DreamStation model.
A user on FB claims to have received a DS2 BiPAP machine.
I'm trying to get more info, but I have doubts.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
I don't know if this is old news for the forum but I just read that Philips has recalled certain masks due to potential risk of serious injury. The masks have magnetic headgear clips or straps which can interfere with certain implanted metallic medical devices and metallic objects in the body causing potential injuries or death, the company said.
https://www.reuters.com/business/healthc...022-09-06/
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-06-2022, 06:54 PM)BobbieM Wrote: I don't know if this is old news for the forum

Hadn't seen it yet. Probably a dedicated thread.

That said, duh. Pacemakers are known to have problems with magnets. So are microwaves, but those aren't being recalled.

Are they going to recall the other masks that use magnets or is it just hammer on Philips.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
BobbieM

This is new:

FDA

Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers

September 6, 2022

The U.S. Food and Drug Administration (FDA) is alerting health care providers that Philips Respironics (Philips) has recalled certain masksExternal Link Disclaimer used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due to a serious safety concern. The recalled masks have magnets (placements shown by black circles in the picture below). They can cause potential injuries or death when the use of a recalled mask with magnets interferes with certain implanted metallic medical devices and metallic objects in the body. 

These potential adverse events can occur in people who use the masks, or in people near a person using the mask. Additionally, the recalled Philips masks may be used with other manufacturers’ BiPAP and CPAP machines. Users of any BiPAP or CPAP machine should check to see whether their mask is one of the recalled Philips masks. 

Manufacturers, such as Philips, are required to submit medical device reports (MDRs) when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would likely cause or contribute to a death or serious injury if the malfunction were to recur. 

As of August 30, 2022, Philips reported 14 serious injuries and 0 deaths related to the use of the recalled masks. The reported injuries included pacemaker failure leading to pacemaker replacement, a need for shunt adjustment, resetting of automatic implantable cardioverter defibrillator, arrhythmia, cognitive changes, headaches, change in heart rate (tachycardia, bradycardia), convulsions (seizures), and irregular blood pressure.

Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: Letter to Health Care Providers | FDA
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-07-2022, 02:41 AM)ST Dog Wrote: That said, duh. Pacemakers are known to have problems with magnets. So are microwaves, but those aren't being recalled.

Are they going to recall the other masks that use magnets or is it just hammer on Philips.

I suppose a 'wearable' microwave oven marketed and labelled as a medical device used to treat a disease would be subject to recall under FDA regulations. But a microwave oven is a kitchen appliance so its a silly comparison. It appears that philips/respironics, once again, has failed to do the required biocompatibility evaluation, so they should get hammered. 

Another fine example of how the present FDA 510(k) process has been bastardized to put dangerous medical devices on the market. Switch to cheap carcinogenic foam? Add magnets to a patient interface? Change the type of plastic material used in a motor? Its no longer substantially equivalent.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-07-2022, 11:46 AM)TimaaaaaaaahRocks Wrote: I suppose a 'wearable' microwave oven marketed and labelled as a medical device used to treat a disease would be subject to recall under FDA regulations. But a microwave oven is a kitchen appliance so its a silly comparison.

Pacemaker users know to avoid magnets and sites that produce strong fields.

I remember in the 80s warning signs about the microwaves in the canteen at the VA hospitals.
But they didn't ban microwaves because they can affect pacemakers. Lots of places, like break rooms at lots of businesses, have microwaves and no warning signs.

There are lots of products with strong magnets that people with devices like pacemakers and defibs need to be wary of and most don't carry warnings, many with stronger magnets than masks use.

Tens of thousands of those mask I use and a dozen complaints warrants a recall? Users of susceptible devices need to be cautious is all.


And what about the other magnetic clasps on masks? The same magnets, it's not like Philips used some new magically strong magnet.

The listings for the Philips masks were far more detailed than the ResMed masks with magnets. Neither were particularly prominent is the online listings (on a second tab at one supplier).
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-07-2022, 02:17 PM)ST Dog Wrote: Tens of thousands of those mask I use and a dozen complaints warrants a recall? Users of susceptible devices need to be cautious is all.

Correction, millions of the masks.

This article says 17 million.
https://www.globenewswire.com/news-relea...of-se.html

And they mention 400mT for the field strength, the same number that ResMed states.

It also mentions 6" in the updated warnings vs the old 2" (50mm). ResMed still says 2" for the same field strength.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-07-2022, 02:17 PM)ST Dog Wrote: Pacemaker users know to avoid magnets and sites that produce strong fields.

I have a pacemaker, located just about where my left shirt pocket would be, if I wore shirts with pockets. The cardiologist told me not to put my phone in my left shirt pocket, but the right pocket would be far enough away. He didn't mention anything else. And I use the microwave in my kitchen several times  day, usually standing in front of it. Never a problem. That's good, because without my microwave I'd probably starve to death. 

My pacemaker is only about three years old. I suspect that recent pacemakers have improved shielding so microwaves aren't a problem.
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
MEDTECHDIVE


Philips Masks

In its assessment of what could go wrong, the FDA said the magnets could lead to increased pressure on the brain or eye in patients with shunts, irregular heartbeat in patients with pacemakers, and failure to shock in patients with cardioverter defibrillators. All of those events, plus others related to the use of aneurysm clips and neurostimulators, could be fatal. 

Philips has responded to the risks by revising its instructions and labeling. The use of the affected masks is now “contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks” who have implanted devices such as pacemakers. 

The warning states magnets with a field strength of 400 mT are used in the masks. The user guide for ResMed’s F20 masks features a warning that states “the magnetic field strength is less than 400 mT” and advises keeping the headgear and frame at least 2 inches from any active medical implant.


Philips recalls 17M sleep apnea masks over magnets that could affect implanted devices | MedTech Dive
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RE: RECALL THREAD-- IMPORTANT PHILIPS DREAMSTATION & SYSTEM ONE USERS
(09-07-2022, 03:34 PM)JJJ Wrote: I have a pacemaker, located just about where my left shirt pocket would be, if I wore shirts with pockets. The cardiologist told me not to put my phone in my left shirt pocket, but the right pocket would be far enough away. He didn't mention anything else. And I use the microwave in my kitchen several times  day, usually standing in front of it. Never a problem. That's good, because without my microwave I'd probably starve to death. 

My pacemaker is only about three years old. I suspect that recent pacemakers have improved shielding so microwaves aren't a problem.

Cell phone emission can be very unpredictable as they dynamically change the output power based on how well it is being received by the cell tower base unit. The strength drops off considerably with distance, hence your cardio Doc's recommendations to avoid the pocket over your pacemaker. Radiated emissions from microwave ovens have dropped considerably over the past 30 years. At the same time pacemakers have become less susceptible to external radio emissions. Radio frequency emissions are not the area of concern for this recall. Many pacemakers and other implanted medical devices are programmed using a permanent magnet. A stray field from a permanent magnet could change the operating mode or place it in a state where it is waiting to be programmed with a proprietary tool. 

Microwave ovens and permanent magnets, two very different things.
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