Trilogy Evo Platform of Ventilators Medical Device Correction

Providing patients with safe and high-quality therapy devices is our top priority. We encourage you to read the field safety notices on this page to learn more about potential issues related to the Trilogy Evo platform of ventilators.

Instructions for Use Update

(2023-CC-SRC-011)

Initiated November 2023

 

This issue affects the Trilogy Evo and Trilogy Evo O2 only.  


During an internal review of the Trilogy Evo and Trilogy Evo O2 Ventilators Instructions for Use (IFUs) manuals, Philips Respironics determined that the Contraindications Statement was incomplete. 


The contraindications listed below are either omitted or listed in other locations within the Instructions for Use and Clinical Manual. 

 

  • The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg.  
  • The AVAPS feature is contraindicated for patients less than 10 kg. 


These have been added to the attached manual addendum for insertion into your current manuals. For complete information, please refer to the Trilogy Evo and Trilogy Evo O2 Ventilators Instructions for Use Field Safety Notice.

Accuracy of FiO2 Delivery

(2022-CC-SRC-049)

Initiated March 2023

 

This issue affects the Trilogy EV300, Trilogy Evo O2,  and Trilogy Evo Universal only.

 

Philips Respironics has discovered, through internal testing, that accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO­2 sensor may indicate a value higher than the device is actually delivering. This may vary based on the patient’s lung capacity, lung resistance, use of a particulate filter, or circuit configuration. In the worst case, this may lead to under delivery of oxygen. 

 

The potential for this hazard is most likely to occur when the oxygen blending module (OBM) is used to manage patients requiring high volumes of oxygen such as scenarios requiring FiO2 setpoint greater than or equal to 70%. 

 

This issue does not affect the Trilogy Evo device which is typically used in the home environment. 

 

The Medical Device Correction provides immediate solutions to address safe continued use of the ventilators. 


Providing patients with safe and high-quality therapy devices is our primary focus. We encourage you to read the Trilogy Evo FiO2 Medical Device Correction to learn more about the mitigating actions you can take to ensure safe continued use.

Environmental Contamination of Device Sensor

(2023-CC-SRC-003)

Initiated April 2023

 

This issue affects all Trilogy Evo Platform devices (Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, Trilogy EV300)


Philips Respironics has detected contamination in the air path of some devices that have been returned from the field. Philips Respironics has confirmed the material is environmental contamination, such as dust and dirt. Extended exposure to these environmental contaminants can lead to buildup of particulate on a flow sensor within the device. This may cause the device to  inaccurately deliver pressure, volume, or flow.

Continued Use of Trilogy Evo Platform of Ventilators

 

Please note, when the mitigating actions specified in the Trilogy Evo platform of ventilators Field Safety Notice are taken, the Trilogy Evo platform of ventilators continues to be an alternative for: 

 

  • Philips Respironics Trilogy 100/200 devices impacted by an issue related to sound abatement foam
  • Philips Respironics V60 and V60 Plus devices impacted by an issue related to the power management PC board 
  • New patients needing treatment 

As a health technology company, it is critical that we have and abide by strong quality and regulatory processes.  The release of the field safety notice further enforces Philips Respironics dedication to patient safety by informing customers about issues that could potentially affect patients, and providing solutions that address these concerns.


If you have any questions or need further support concerning this issue, please contact your local Philips representative.


We appreciate your patience and trust as we continue to act quickly to release this correction.

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