FDA: CPAP Machines May Not Deliver The Right Treatment

FDA: CPAP Machines May Not Deliver The Right Treatment

Introduction

More than 1,000 apparently fixed Philips DreamStation CPAP and BiPAP machines are being recalled owing to a serial number mismatch, which may cause the equipment to fail to deliver sufficient breathing support to users.

The Philips DreamStation recall was notified by the US Food and Drug Administration (FDA) warning that repaired CPAP and BiPAP devices may fail to provide the right prescription or default to factory settings. They may also fail to administer therapy completely, offering major hazards to people who rely on sleep apnea equipment.

Philips issued the recall after receiving 43 complaints about difficulties with repaired DreamStation CPAP and BiPAP equipment. According to the manufacturer, no injuries or fatalities have been attributed to the recall.

The devices, which were previously subject to a massive Philips CPAP recall in June 2021 and then refurbished and returned to users, may have been allocated erroneous or duplicate serial numbers during programming, according to the recall notice. This issue may cause the device to use the incorrect prescription settings or to default to factory settings. In certain situations, they may completely fail to provide treatment.

According to the recall, there is no warning or indication that the devices are not functioning properly, and failure to provide treatment might result in respiratory failure, heart failure, significant injury, or death. As a result, the FDA has classified the recall as Class I, indicating that the agency believes the condition might cause serious harm or death.