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Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway… — recall 62548

Health Canada — Medical Devices · Canada · 2021-06-23 · Type I

As described by Health Canada — Medical Devices: Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiPAP), and Mechanical Ventilators (2021-06-14)

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Agency
Health Canada — Medical Devices
Recall identifier
62548
Date of alert
2021-06-23
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Please view following link for related information. Philips has become aware of two (2) issues that may pose a risk for patients or users of Philips Respironics branded Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BIPAP), and Mechanical Ventilators: Philips has determined from user reports and testing that the Polyester-Based Polyurethane (PE-PUR) sound abatement foam used in Philips continuous and non-continuous ventilators may degrade under certain circumstances, and the degraded particles could potentially enter the air pathway of the device. This issue affects Philips Respironics branded CPAP's, Bi-Levels, and Mechanical Ventilators. The results of testing performed by Philips indicate that the PE-PUR sound abatement foam used in these devices may emit certain chemicals. Our investigation to date indicates that this emission occurs during initial operation and may possibly continue throughout the device's useful life. These issues impact all device product platforms manufactured with Polyester Polyurethane (PE-PUR) sound abatement foam. There is no specific population of device serial numbers which are impacted.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/continuous-positive-airway-pre

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