After a massive recall caused sleepless nights for millions of sleep apnea patients worldwide, some users say the company behind the recall, Philips Respironics, is not delivering on its promises.
Philips Respironics announced a voluntary recall last year of some of the most popular sleep aids prescribed by doctors for patients with apnea – several different CPAP, Bi-PAP and ventilator devices – after it was discovered that noise canceling foam inside could disintegrate and be inhaled by the user.
The Food and Drug Administration has warned that the foam could be toxic or carcinogenic.
The news came as a surprise to North Texas’ Jackie Wright.
“I’ve been using a CPAP machine for way over, I would say, at least 15 years,” Wright said. “The machine has helped me tremendously.”
But Wright said she only learned about the recall and the risks inside her device by chance after visiting a doctor when it appeared unexpectedly.
“I was at my doctors and they said, ‘Oh, your machine is rappelling. And I said, ‘I didn’t know anything about that.'”
Given the scale of the recall, which affected more than 15 million devices, Philips Respironics said it would take up to a year to repair or replace each device.
The announcement left patients like Wright with a false choice: use a risky device or risk not waking up at all given their apnea disorder.
Wright waited a year, then received more bad news.
“Now [Philips Respironics] said, ‘Sorry, it’s too old. …You are only eligible for $50.’”
Even though Wright’s System One CPAP device was included in the original recall list, Philips said that older devices “exceeded their warranty and useful life,” meaning these older devices old ones are not eligible for new parts.
The company offers these patients two options: return the old machine for a $50 check or see a doctor for a new prescription to get a newer model.
Philips Respironics tells NBC 5 Responds, in part, “One of the most complex aspects of the recall was creating remediation options for older devices…such as the System One.”
Since the devices have been abandoned, it does not have a repair option.
After NBC 5 Responds contacted Philips about Wright’s situation, she was able to get a new prescription and her request for a replacement was expedited.
Wright now has a new CPAP machine and she hopes what happened to her will be part of a new model for the company.
“They should take care of everyone’s machines,” Wright said.
Philips Respironics said it plans to repair or replace the vast majority of devices affected by the recall by the end of this year.
To learn how to register your device with Philips Respironics, click here.
Below is a full list of affected Philips Respironics devices, according to the FDA:
CPAP and BiPAP devices
| Device type | Model name and number (all serial numbers) |
| Continuous ventilator, minimal ventilatory support, use of facilities | E30 (Emergency Use Authorization) |
| Continuous ventilator, non-life support | DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ |
| Non-continuous fan | SystemOne (Q series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto |
Fans
| Device type | Model name and number (all serial numbers) |
| Continuous fan | Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent |
| Continuous ventilator, minimal ventilatory support, use of facilities | A-Series BiPAP Hybrid A30 (not for sale in the US), A-Series BiPAP V30 Auto |
| Continuous ventilator, non-life support | BiPAP A40 A-Series, BiPAP A30 A-Series |
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