Philips Respironics has issued a software update and revised user instructions for its Trilogy ventilators to address previously reported and new safety risks.

RT’s Three Key Takeaways:

  1. Critical Software Update Issued: Philips Respironics has released a software update for Trilogy ventilators to fix multiple safety issues, including inaccurate oxygen delivery and false alarms, which could pose serious health risks.
  2. Revised User Instructions: Along with the software update, Philips has provided new instructions for use, including the requirement of a particulate filter to prevent contamination of the flow sensor.
  3. Serious Health Risks: The affected ventilators have been linked to nine injuries and one death, leading the FDA to classify the recall as the most serious type.

Philips Respironics is correcting its Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators using Software Version 1.05.10.00 (US) to resolve several previously reported and also new safety issues that may affect the device’s ability to support patient breathing. 

The issues include:

  • An inaccurate display of oxygen being delivered to the patient where the patient may receive less than is indicated on the screen.
  • A software-related issue causing false power loss or battery depleted alarms which may lead to a stoppage of therapy.
  • Flow Sensor Reading Compensation associated with volume measurement inaccuracies
  • Software Alarm Errors (associated with obstruction alarm, high and low tidal volume alarms when using A/C-VC mode, leakage alarm, AEV failure alarm.)
  • HIP/LIP – HEP/LEP technical alarm threshold to eliminate nuisance alarms. 
  • Addition of high-priority vent service required alarm criteria to detect contamination on flow sensor mesh.  
  • E110 Vent INOP issue triggered by motor stalls.
  • Spontaneous breath percent calculation.
  • Floating point calculations.
  • Translation strings to avoid confusion for customers.
  • User interface issues.
  • Adjustment of maximum alarm volume setting to meet standards requirements.
  • Software errors, as well as data corruption and transfer of data with Care Orchestrator and Care Orchestrator Essence.

Additionally, Philips Respironics is also correcting these devices using the Philips Respironics User Manual addendum, ie L1154778b03, Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 Clinical & Caregiver Manual Addendum, for the previously reported safety issues as below:

  • The accumulation of environmental debris on the internal machine flow sensor, which could partially block pressure, volume, or air flow.
  • Instructions for use translations in Korean, Spanish, and Chinese languages.
  • Missing contraindications in the instructions for use.

The use of affected products may cause serious adverse health consequences, including hypoventilation, hypoxia, and death. There have been nine reported injuries. There has been one reported death.

Philips Respironics Trilogy ventilators provide pressure support, pressure control, or volume control during breathing support. These devices are intended to be used for people who need help with breathing by providing continuous or intermittent breathing support. They are used in medical, home, and non-emergency transport settings, for example a wheelchair, personal vehicle, or ambulance.

This recall involves correcting devices and does not involve removing them from where they are used or sold. The US Food and Drug Administration has identified this recall as the most serious type. 

Affected product:

  • Product names: Trilogy Evo, Trilogy EV300, Trilogy Evo O2, Trilogy Evo Universal
  • Unique device identifier/Model: 00606959051942/Trilogy Evo, 00606959052017/Trilogy EV300, 00606959061019/Trilogy Evo O2, 00606959052000/Trilogy Evo Universal

What to Do

On July 16, Philips Respironics sent all affected customers an Urgent Medical Device Correction – Update recommending the following actions:

  • Immediately update device software following the instructions provided in the letter.
    • The company will follow up to make sure all devices have been updated to Software Version 1.05.10.00 (US).
    •  Separate instructions are available for both DME/homecare users and hospital users on how to download the software corrections.
  • Follow the instructions in the User Manual addendum that requires the use of a Phillps-approved particulate filter to prevent environmental contamination.
  • Review the information in appendix A and B of the letter to make sure all recommended mitigations are followed until the software update is complete.
  • Share the updated correction information with everyone who needs to be aware, both within the organization and any place where potentially affected devices may have been transferred.
  • Distributors: Distribute the notification and all relevant appendices to appropriate physicians, clinicians, patients, and/or users.

Customers in the US with questions about this recall should contact [email protected] or their Philips representative at 1-800-722-9377.

Photo caption: A patient is treated with Philips Trilogy EV300 in the hospital.

Photo credit: Philips