'Nobody should have to go through this' Iowa woman stuck waiting for recalled CPAP machine

A West Des Moines woman is stuck in limbo waiting for a new CPAP machine, worried her current machine is doing more harm than good. She's one of hundreds in the Des Moines metro who had their machine recalled.

A West Des Moines woman is stuck in limbo waiting for a new CPAP machine, worried her current machine is doing more harm than good. She's one of hundreds in the Des Moines metro who had their machine recalled.

MORE HARM THAN GOOD. THIS IS WHAT IT DOES. YEAH. THANKS FOR THAT, GAYLE PETERSON PUTS ON THIS CPAP MASK EACH AND EVERY NIGHT. IT’S NOT A FASHIONABLE LOOK. UNCOMFORTABLE TO PUT ON IN FRONT OF A CAMERA, BUT NEVER AVERY TO WEAR EACH NIGHT FOR A WOMAN WHO’S HAD SLEEP APNEA AND USED A MACHINE LIKE THIS FOR MORE THAN A DECADE, IF YOU GET A GOOD SEAL ON IT, YOU SHOULDN’T BE ABLE TO OPEN YOUR MOUTH. IN MAY OF LAST YEAR, SHE RECEIVED A LETTER SAYING HER MACHINE WAS BEING RECALLED. INTERNAL FILTRATIONS INSIDE THE MACHINE. IT CAN BREAK OFF AND YOU CAN INGEST IT THROUGH YOUR LUNGS, THROUGH THE BREATHING PART OF THE MACHINE, SHE SAYS. THE MACHINE IS TAKING THAT FILTER AND TURNING IT BLACK. IT HAD A BURNT SMELL IN IT AND IT’S NEVER SMELLED THAT WAY BEFORE. AND AFTER FILLING OUT THE NECESSARY PAPERWORK, SHE SAYS, AND EMAILS SHOW PHILIPS NEEDED MORE INFO. THEY WON’T EVEN ACKNOWLEDGE THEY’VE EVEN RECEIVED THOSE DOCUMENTS. I CALLED AND CALLED AND CALLED TO THE POINT WHERE I GET SO ANGRY. I’M SO MAD BY THE TIME I GET OFF THE PHONE, I HAVE TO GO TAKE A WALK BECAUSE I’M SO UPSET. PETERSON SAYS SHE AND HER DOCTOR HAVE BOTH REACHED OUT, PROVIDING DOCUMENTATION. PETERSON SAYS SHE CAN’T SEND IN HER MACHINE BECAUSE SHE CAN’T LIVE WITHOUT IT. THE DOCTOR SAID IT. THE LONGER I WOULD GO WITHOUT IT, THE HARDER IT WOULD BE FOR MY ORGANS TO FUNCTION. BUT NOW SHE’S WORRIED SHE CAN’T LIVE WITH IT. I DON’T WANT TO BE ANGRY AT A COMPANY THAT IS HELPING KEEP ME ALIVE, BUT AT THE SAME TIME, NOBODY SHOULD HAVE TO GO THROUGH THIS. THE FDA SAYS 385 PEOPLE HAVE DIED DUE TO THE FOAM OR SUSPECTED FOAM BREAKDOWN. AND HOW MANY OF OF THESE CASES HAVE YOU DEALT WITH AS A AS A DOCTOR AT MERCY? OH, SEVERAL HUNDRED NOW. DR. STEPHEN GRANT IS THE DIRECTOR OF SLEEP MEDICINE AT MERCY ONE, THOUGH HE’S DEALT WITH SEVERAL HUNDRED PATIENTS WITH THIS RECALL, HE’S ONLY HAD A FEW STUCK IN THE SAME SITUATION AS PETERSON AND HAS NOT HAD ANY HEALTH ISSUES FROM IT. IF YOUR MACHINE IS PART OF THE RECALL AND IS OLDER THAN FIVE YEARS OLD, HE SUGGESTS GETTING A NEW ONE ALTOGETHER. AND I WOULD JUST TRY AND GET MY PATIENTS KIND OF STARTED OVER AND ON A NEW FOOT WITH A NEW MACHINE. AND FOR ANY CPAP MACHINE, CLEAN IT WITH SOAP AND WATER INSTEAD OF OZONE CLEANERS. PETERSON JUST WANTS A NEW ONE, NOT A FASHION ACCESSORY. I’D LIKE TO HAVE, BUT IT’S ONE I’M STUCK WITH. AND TO BE STUCK WITH SOMETHING THAT MAY NOT BE A FASHION ACCESSORY, BUT ONE THAT PROPERLY WORKS, THAT’S WHY I CAME TO YOU GUYS. MAYBE I CAN GET SOMETHING DONE ABOUT THE PROBLEM IN WEST DES MOINES

'Nobody should have to go through this' Iowa woman stuck waiting for recalled CPAP machine

Gale Petersen puts on a CPAP mask each and every night, plugging her nostrils to help her breathe while she sleeps."It's not a fashionable look," she says with a quick laugh while putting it on. Though not fashionable, it is necessary for her. She's had sleep apnea for more than a decade and used a machine from Philips Respironics. In May of last year, she received a letter saying her machine was being recalled, one of thousands of machines. The company says internal foam inside the machine may degrade and may be ingested by the person using it, or it can off-gas certain chemicals. Since April 2021, Philips has reported 385 deaths to the FDA reportedly associated with the foam breakdown. Petersen says her machine is turning her filter black, and she's worried about what it could be doing to her lungs. She says she filled out the needed paperwork, but Philips needs more information."They won't even acknowledge they've even received those documents," she said. "I called and called and called to the point where I get so mad. By the time I get off the phone, I have to go take a walk because I'm so upset."Petersen says she can't send in her machine because she can't live without it. Now, she's worried she can't live with it. "I don't want to be angry at a company that is helping keep me alive," she said. "But at the same time, nobody should have to go through this."She's not alone in needing a recalled replacement; Mercy One Sleep Center has dealt with a few hundred of them. Dr. Stephen Grant, the director of sleep medicine for Mercy, says only a few have been stuck in the same limbo as Petersen. "I would just try and get my patients kind of started over and, you know, on a new foot with a new machine," he said, acknowledging that due to insurance coverage, that can't happen for everyone. Though, he suggests getting a new machine if the one users have is older than five years. He also suggests, and the FDA and Philips do too, not to use ozone cleaners for CPAP machines. KCCI Investigates emailed Philips for an interview regarding Petersen's case. The company did send a statement, but didn't address her case specifically. A Philips' spokesperson also said the company would reach out to Petersen."That's why I came to you guys," she told KCCI Investigates. "Maybe I can get something done about the problem."Phillips said the company has remediated roughly 4.3 million devices worldwide, and those who have not registered their device should do so to get a recalled machine. The company's full statement is posted below.In 2021, Philips Respironics determined from user reports and initial testing that there are possible risks to users related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in specific CPAP, BiPAP and mechanical ventilator devices. Following the issuance of the recall notification in June 2021, Philips Respironics initiated a global program to remediate the affected devices through replacement or repair.We regret the concern that this recall notification has caused for patients and care providers, and we deeply apologize for that. We understand how important these sleep therapy devices and ventilators are to the patients and how they improve their lives every day and night. Resolving this for our patients has been, and remains, our highest priority. To date, a total of approximately 4.3 million devices have been remediated globally, of which approximately 2.4 million devices in the US. Patients with any remaining sleep therapy device currently in use that has not been remediated yet and not registered yet, are requested to register their product to facilitate the remediation of their devices.Over the past two years, together with five independent certified testing laboratories in the US and Europe, as well as other qualified third-party experts, and in consultation with regulators around the world, Philips Respironics has conducted a comprehensive test and research program on the PE-PUR foam to determine the prevalence of foam degradation, better assess and scope the potential patient health risks related to possible emission of particulate matter from degraded foam and volatile organic compounds.The extensive data and results now available for sleep therapy devices are positive and reassuring. Results for the first-generation DreamStation, System One and DreamStation Go devices indicate that the occurrence of visible foam degradation is low and volatile organic compounds and particulate emissions related to foam degradation are within the applicable safety limit and are unlikely to cause appreciable harm to health in patients. Based on 13 independent epidemiological studies identified from a systematic literature review, no association has been established between use of Positive Airway Pressure (PAP) devices, including Philips Respironics PAP devices, and risk of cancer in patients with obstructive sleep apnea (OSA). Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.

WEST DES MOINES, Iowa —

Gale Petersen puts on a CPAP mask each and every night, plugging her nostrils to help her breathe while she sleeps.

"It's not a fashionable look," she says with a quick laugh while putting it on.

Though not fashionable, it is necessary for her. She's had sleep apnea for more than a decade and used a machine from Philips Respironics. In May of last year, she received a letter saying her machine was being recalled, one of thousands of machines.

The company says internal foam inside the machine may degrade and may be ingested by the person using it, or it can off-gas certain chemicals. Since April 2021, Philips has reported 385 deaths to the FDA reportedly associated with the foam breakdown.

Petersen says her machine is turning her filter black, and she's worried about what it could be doing to her lungs. She says she filled out the needed paperwork, but Philips needs more information.

"They won't even acknowledge they've even received those documents," she said. "I called and called and called to the point where I get so mad. By the time I get off the phone, I have to go take a walk because I'm so upset."

Petersen says she can't send in her machine because she can't live without it. Now, she's worried she can't live with it.

"I don't want to be angry at a company that is helping keep me alive," she said. "But at the same time, nobody should have to go through this."

She's not alone in needing a recalled replacement; Mercy One Sleep Center has dealt with a few hundred of them. Dr. Stephen Grant, the director of sleep medicine for Mercy, says only a few have been stuck in the same limbo as Petersen.

"I would just try and get my patients kind of started over and, you know, on a new foot with a new machine," he said, acknowledging that due to insurance coverage, that can't happen for everyone. Though, he suggests getting a new machine if the one users have is older than five years. He also suggests, and the FDA and Philips do too, not to use ozone cleaners for CPAP machines.

KCCI Investigates emailed Philips for an interview regarding Petersen's case. The company did send a statement, but didn't address her case specifically. A Philips' spokesperson also said the company would reach out to Petersen.

"That's why I came to you guys," she told KCCI Investigates. "Maybe I can get something done about the problem."

Phillips said the company has remediated roughly 4.3 million devices worldwide, and those who have not registered their device should do so to get a recalled machine. The company's full statement is posted below.

In 2021, Philips Respironics determined from user reports and initial testing that there are possible risks to users related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in specific CPAP, BiPAP and mechanical ventilator devices. Following the issuance of the recall notification in June 2021, Philips Respironics initiated a global program to remediate the affected devices through replacement or repair.

We regret the concern that this recall notification has caused for patients and care providers, and we deeply apologize for that. We understand how important these sleep therapy devices and ventilators are to the patients and how they improve their lives every day and night. Resolving this for our patients has been, and remains, our highest priority. To date, a total of approximately 4.3 million devices have been remediated globally, of which approximately 2.4 million devices in the US. Patients with any remaining sleep therapy device currently in use that has not been remediated yet and not registered yet, are requested to register their product to facilitate the remediation of their devices.

Over the past two years, together with five independent certified testing laboratories in the US and Europe, as well as other qualified third-party experts, and in consultation with regulators around the world, Philips Respironics has conducted a comprehensive test and research program on the PE-PUR foam to determine the prevalence of foam degradation, better assess and scope the potential patient health risks related to possible emission of particulate matter from degraded foam and volatile organic compounds.

The extensive data and results now available for sleep therapy devices are positive and reassuring. Results for the first-generation DreamStation, System One and DreamStation Go devices indicate that the occurrence of visible foam degradation is low and volatile organic compounds and particulate emissions related to foam degradation are within the applicable safety limit and are unlikely to cause appreciable harm to health in patients.

Based on 13 independent epidemiological studies identified from a systematic literature review, no association has been established between use of Positive Airway Pressure (PAP) devices, including Philips Respironics PAP devices, and risk of cancer in patients with obstructive sleep apnea (OSA). Two rigorous independent studies showed no statistical difference in cancer risk between OSA patients who used Philips Respironics PAP devices versus other brands of PAP devices. Eleven other epidemiological studies provided little additional insight into this question, but their results generally suggested no excess risk of cancer associated with PAP use for OSA.

'Nobody should have to go through this' Iowa woman stuck waiting for recalled CPAP machine

A West Des Moines woman is stuck in limbo waiting for a new CPAP machine, worried her current machine is doing more harm than good. She's one of hundreds in the Des Moines metro who had their machine recalled.

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