Omaha hospitals, local CPAP users impacted by Philips ventilator recall
OMAHA, Neb. (WOWT) - A recall on continuous and non-continuous ventilators made by Philips has many CPAP and BiPAP users concerned.
According to the FDA, the recall is a Class I recall — the most serious type, as “use of the devices could cause serious injuries or death.”
One of the recalled machines includes the CPAP DreamStation, which Bellevue resident Greg Baldwin used to use every night.
“My sleep is horrible now, I wake up three to four times a night now,” he says.
Baldwin began using the CPAP in August 2020 after being diagnosed with congestive heart failure likely cause by his sleep apnea.
Now that his device has been recalled, he’s frustrated.
“I called, give them the serial number off my machine, and they said, ‘Yup, it’s recalled. We suggest you stop using it right now. We’ve got you registered, so once we figure out what we’re doing, we’ll let you know.’ ”
Baldwin says his frustration lies with both Philips and his local provider, neither of which notified him of the recall that was announced in mid-June. Instead, he found out through Facebook.
Without his machine, Baldwin fears something bad could happen to him.
“It scares me for my wife and kids,” he says. “What happens if I don’t wake up? That scares me.”
The recall is due to a noise-cancelling foam that’s used in the machines to reduce the sound and vibration.
“According to Philips Respironics, there is a risk this foam can break down, enter the device’s airflow path, and be ingested or inhaled by the patient,” says Dr. Matthew Dennis, the medical director of Children’s respiratory and home health care in a pre-recorded message that was sent to their patients.
Officials with Children’s Hospital say they were impacted by the recall and had to notify their home health care patients who use these types of machines.
“If your child is using a recalled ventilator, BiPAP device or CPAP device, we recommend placing a filter inline, as described in attached literature, and continuing to use the device,” Dr. Dennis goes on to say in the video as a general recommendation for their patients.
Nebraska Medicine and Methodist Health System say none of the ventilators they use were impacted by the recall, but CHI Health was.
In a statement to 6 News, CHI Health says they “discontinued use of the devices once we were made aware of the recall by Philips Respironics. The recall affects a small percentage of the devices we use.”
According to the FDA, side effects from inhalation and digestion of the debris “could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects.”
Baldwin says he’s worried he might be impacted.
“Yes, I have had breathing problems and sinus stuff since I started using this machine. Didn’t think anything of it.”
Baldwin is hoping that by sharing his experience, he can make others aware of this issue. After posting about it on his Facebook page, he tells 6 News that two people reached out to him thanking him, citing they didn’t know about the recall either.
The FDA says there have been more than 1200 complaints and more than 100 injuries reported because of this issue. For a complete list of the devices that have been recalled, visit the FDA Philips recall page.
Copyright 2021 WOWT. All rights reserved.