Health Canada issues recall for popular sleep apnea ventilator devices

Health Canada has issued a recall for the Omnilab Advanced ventilators manufactured by Respironics Inc., also trading as Philips RS North America LLC. These ventilators are commonly used in the treatment of sleep apnea, a condition where a person’s breathing is interrupted during sleep. Sleep apnea can lead to daytime fatigue, high blood pressure, and other complications if left untreated. The Omnilab Advanced ventilators are crucial for patients requiring respiratory support, especially those with conditions affecting their ability to breathe effectively.

Issue Details:

  • The affected ventilators may experience a ventilator inoperative alarm, which occurs when the device detects an internal error or a condition that may affect therapy.
  • This alarm can manifest in several ways, including intermittent reboots lasting 5-10 seconds, with or without a return to factory default settings.
  • In some cases, three reboots within a 24-hour period can cause the device to enter a ventilator inoperative state, halting therapy and triggering audible and visual alarms.
  • There is also a risk that the device may enter a ventilator inoperative state without any preceding reboot.

Risk to Patients:
These issues could lead to interruptions or loss of therapy, potentially resulting in serious consequences such as hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or even death, especially in vulnerable patients relying on these devices for critical respiratory support.

Recall Information:

  • Recall start date: March 25, 2024
  • Recall class: Type II
  • Health Canada Identification number: RA-75324
  • Model/catalogue number 1044278

What to Do:
If you are using an Omnilab Advanced ventilator, it is important to contact the manufacturer for additional information and guidance. Following the manufacturer’s instructions is crucial to ensure the safe and effective use of these devices.

Via Health Canada

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