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  5. Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction
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Philips Respironics, Inc. Recalls Trilogy Evo Continuous Ventilators due to a Software-Related Possible Power Malfunction

Please be aware, this recall is a correction, not a product removal. Philips Respironics is providing a software update for its Trilogy Evo continuous ventilators.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices without the software update may cause serious injuries or death.

Recalled Product

  • Product Names: Trilogy EVO, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal
  • Product Codes: All Software Versions Except 1.05.06.00
  • Distribution Dates: March 20, 2019 to February 16, 2024
  • Devices Recalled in the U.S.: 90,905
  • Date Initiated by Firm: March 19, 2024

Device Use

The Trilogy ventilators use a microprocessor-controlled blower to provide pressure support, pressure control, or volume control during breathing support. These devices are intended for the care of individuals who require assistance with breathing and provide continuous or intermittent support. They are suitable for use in medical, home, and non-emergency transport settings, for example a wheelchair, personal vehicle, or ambulance.

Reason for Recall

Philips Respironics, Inc. has notified customers to update to the latest software version (1.05.06.00) of its Trilogy Evo continuous ventilator devices due to a possible power malfunction. Due to a software issue, these ventilators can issue a “Battery Depleted” or “Loss of Power” alarm while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms. All Trilogy Evo ventilators (Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300) are susceptible to this problem, except those ventilators with the software version 1.05.06.00 installed.

The software algorithm that calculates remaining battery life can malfunction and cause the ventilator to either:

  • Issue a “Loss of Power” alarm that stops assisted breathing support therapy while operating on battery power alone.
  • Issue a “Battery Depleted” alarm while continuing therapy if plugged into a permanent power source, such as AC or DC power.

This situation occurs only when all of the following conditions are met:

  • Software other than version 1.05.06.00 is installed on the ventilator,
  • The ventilator is operating in CPAP or PSV mode, and
  • The ventilator is not able to detect the respiratory effort of the patient for at least 10 minutes and 55 seconds.

The use of the affected ventilators may result in ventilator power down and no delivery of therapy to the patient, even though the battery is not depleted. This could cause serious adverse health consequences, including hypoventilation and death.

As of May 13, 2024, there are no reports of death or serious injury related to this issue in the Manufacturer and User Facility Device Experience (MAUDE) database, which contains medical device reports (MDRs) of adverse events.

Who May be Affected

  • People who receive breathing support using a Philips Trilogy Evo ventilator.
  • Health care providers who provide care for patients using a Philips Trilogy Evo ventilator.

What to Do

On March 19, 2024, Philips Respironics sent all affected customers an Urgent Medical Device Correction Notice. The letter notified customers to update to the latest version (1.05.06.00), which does not experience this issue. The software is available as a no‐charge download on MyP4P. For ventilators not updated to the latest software version, all these safety measures should be followed:

  • Ensure the Backup Ventilation is set to ON and the apnea interval setting is correct and appropriate based on the clinical assessment of the patient. This will minimize the chances for a CPAP or PSV supported patient to encounter a loss of power malfunction.
  • Keep the device plugged into AC or DC power to the greatest extent possible.
  • Keep an alternative form of ventilation on standby. If the device must be unplugged for patient transport, plug the device back in as soon as you reach your destination.
  • Do not leave a patient unsupervised while operating on battery power alone.
  • Continue to follow typical monitoring protocols for ventilated patients such as use of backup monitors, including pulse oximetry or heart rate.

In addition:

  • Distribute the Urgent Medical Device Correction Notice to all those responsible for setting up and supervising patients that use these devices and to any organizations where products have been distributed.
  • Complete the Urgent Medical Device Correction Response Form to confirm receipt of Philips’ letter.

Contact Information

Customers in the U.S. with questions about this recall should contact Philips Respironics at 1-800-345‐6443 for homecare customers or 1-800-722‐9377 for hospital customers.

Additional Resources:

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

 

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