Well, that's the way it goes these days.
Back on June 30th of this year, the FDA announced this:
The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
I somehow missed the news which was covered by the major newspapers.
I found out today on a YouTube video, HaHa.
So I looked further. Phillips has issued this statement:
URGENT: Medical Device Recall
Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation.
These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.
It is recommended that you stop using your equipment and consult your doctor.
I am one of 10 million people just in the US who use CPAP at night to breathe properly and avoid serious health issues including heart disease and stroke. And car accidents (we fall asleep at the wheel).
So, I called the medical equipment company who sold me the machine and instructed me on its use. They were stoic; "We expected the manufacturer to inform you". Phillips did not inform me, like most people, I have read. They sold 30 million of these dangerous machines. I called my doctor who prescribed it. They said they expected the medical supply company to inform me.
Truck drivers who have been diagnosed with sleep apnea are required to use CPAP/Bipap to keep their jobs (It was a truck driver who filed the first class action lawsuit, apparently), and we patients are all electronically monitored constantly as to our nightly follow through. I get a phone call when there is a fluctuation in my CPAP usage. Medical Big Brother.
So, my doctor, the medical equipment company, and my insurance company are all monitoring me, but none of them (all of them knew about the recall) thought to contact me.
I hope this is informative to other CPAP users.
.
.
https://www.fda.gov/medical-devices...-machines-recalled-due-potential-health-risks
.
.
Back on June 30th of this year, the FDA announced this:
The U.S. Food and Drug Administration (FDA) is alerting people who use Philips Respironics ventilators, BiPAP, and CPAP machines and their health care providers that Philips Respironics has recalled certain devices (see table below) due to potential health risks. The polyester-based polyurethane (PE-PUR) sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device.
I somehow missed the news which was covered by the major newspapers.
I found out today on a YouTube video, HaHa.
So I looked further. Phillips has issued this statement:
URGENT: Medical Device Recall
Philips Respironics is voluntarily recalling the below devices due to two (2) issues related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in Philips Continuous and NonContinuous Ventilators: 1) PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user, and 2) the PE-PUR foam may off-gas certain chemicals. The foam degradation may be exacerbated by use of unapproved cleaning methods, such as ozone (see FDA safety communication on use of Ozone cleaners), and off-gassing may occur during operation.
These issues can result in serious injury which can be life-threatening, cause permanent impairment, and/or require medical intervention to preclude permanent impairment.
It is recommended that you stop using your equipment and consult your doctor.
I am one of 10 million people just in the US who use CPAP at night to breathe properly and avoid serious health issues including heart disease and stroke. And car accidents (we fall asleep at the wheel).
So, I called the medical equipment company who sold me the machine and instructed me on its use. They were stoic; "We expected the manufacturer to inform you". Phillips did not inform me, like most people, I have read. They sold 30 million of these dangerous machines. I called my doctor who prescribed it. They said they expected the medical supply company to inform me.
Truck drivers who have been diagnosed with sleep apnea are required to use CPAP/Bipap to keep their jobs (It was a truck driver who filed the first class action lawsuit, apparently), and we patients are all electronically monitored constantly as to our nightly follow through. I get a phone call when there is a fluctuation in my CPAP usage. Medical Big Brother.
So, my doctor, the medical equipment company, and my insurance company are all monitoring me, but none of them (all of them knew about the recall) thought to contact me.
I hope this is informative to other CPAP users.
.
.
https://www.fda.gov/medical-devices...-machines-recalled-due-potential-health-risks
.
.
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