Agency warns reworked CPAP, BiPAP machines may deliver inaccurate or insufficient therapy
By Physician’s Briefing Staff HealthDay Reporter
MONDAY, April 10, 2023 (HealthDay News) — The U.S. Food and Drug Administration has issued another warning about certain sleep apnea machines made by Philips Respironics. Already the subject of a 2021 recall, some of the company’s repaired continuous positive airway pressure (CPAP) machines may still be dangerous to use, the agency said in an alert issued Friday.
The original problem with some of the machines was that foam that is meant to dull noise was breaking off from inside the machine and going into the mouths of people using the unit for sleep apnea. Inhaling the foam can cause “serious injury, which can be life-threatening,” Philips noted in its original recall notice.
The latest issue with some of the machines is that the company gave repaired machines the wrong or duplicate serial numbers, the latest FDA alert said. That may lead to the devices delivering the wrong prescription to sleep apnea patients. If receiving the wrong prescription, patients may not receive any CPAP benefits.
Philips’ Friday statement acknowledged the repair issues, including that a “limited amount [1,200] of remediated first-generation DreamStation CPAP devices had been incorrectly programmed with either an incorrect serial number or a duplicate serial number.” The company is notifying patients if their machines may provide them with the wrong prescriptions.
The FDA has tracked complaints numbering 98,000 since the 2021 recall. People have reported having respiratory problems, pneumonia, dizziness, chest pain, infections, and cancer. The company said it has received 43 complaints about the repaired machines. No one has reported injury or death.
More than 20 different Philips devices have been recalled, including the A-Series BiPAP ventilators, the DreamStation CPAP machines, and the Trilogy 100 and 200 style ventilators.
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