Some apnea patients face challenges seeking replacement devices under recall – NBC Chicago
After a massive recall cost millions of sleep apnea patients worldwide sleepless nights, some users are concerned that the company behind the recall, Philips Respironics, isn’t delivering on its promises.
Philips Respironics last year announced a voluntary recall of some of the most popular sleep-aid devices prescribed by doctors for apnea patients — several different CPAP, Bi-PAP and ventilator devices — after discovering that a noise-canceling device inside The causative foam may disintegrate and may be inhaled by the user.
The Food and Drug Administration warns that the foam may be toxic or carcinogenic.
The news came as a surprise to Jackie Wright of North Texas.
“I’ve been using a CPAP machine for quite some time, I would say, at least 15 years,” Wright said. “The machine has helped me a lot.”
But Wright said she only learned about the recall and the risks inside her device by chance after a doctor’s visit when it unexpectedly surfaced.
“I was at my doctors and they said, ‘Oh, your machine is being recalled.’ 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 faced patients like Wright with a stark choice: Use risky equipment or risk not waking up at all given your apnea disorder.
Wright waited a year and then got more bad news.
“now [Philips Respironics] Saying, ‘Sorry, this is too old. … You only deserve $50.'”
Although Wright’s System One CPAP device was included in the original recall list, Philips stated that the older devices are “beyond their warranty and useful life,” meaning older devices are not eligible for the new parts.
The company is giving those patients two options: Return the old machine for a check for $50 or visit a doctor for a new prescription to get a new model.
Philips Respironics told NBC 5 Responds in part, “One of the more complicated aspects of the recall is making remediation options for older devices … such as the System One.”
Since the equipment is discontinued, there is no repair option.
When NBC 5 Responders contacted Phillips about Wright’s condition, she was able to obtain a new prescription and her replacement claim was expedited.
Wright now has a new CPAP device and expects what happened to her to be part of a new pattern for the company.
Wright said, “They should be taking care of everybody’s machines.”
Philips Respironics said it expects to repair or replace most of the 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 the full list of Philips Respironics machines that are affected, according to FDA,
CPAP and BIPAP devices
| type of equipment | Model name and number (all serial numbers) |
| continuous ventilator, minimal ventilatory support, facility use | e30 (emergency access authorization) |
| continuous ventilator, non-life support | DreamStation ASV, DreamStation ST – AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ |
| continuous ventilator | SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto |
artificial respiration
| type of equipment | Model name and number (all serial numbers) |
| continuous ventilator | Trilogy 100, Trilogy 200, Garbin Plus, Eris, Lifevent |
| continuous ventilator, minimal ventilatory support, facility use | A-Series BiPAP Hybrid A30 (not marketed in the US), A-Series BiPAP V30 Auto |
| continuous ventilator, non-life support | A-Series BIPAP A40, A-Series BIPAP A30 |
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