PHILIPS 17-19 Clinical Bulletin Trilogy Evo O2 Ventilators Instructions
- July 4, 2024
- Philips
Table of Contents
PHILIPS 17-19 Clinical Bulletin Trilogy Evo O2 Ventilators
Product Information
Specifications
- Product Name: Trilogy Evo Ventilators
- Manufacturer: Philips Respironics
- Model: Trilogy Evo and Trilogy Evo O2 Ventilators
- Manuals: Instructions for Use (IFU), Clinical and Caregiver Manual Addendum
Product Usage Instructions
Sleep Updates
No action is required for DreamStation devices in Australia or New Zealand regarding the device testing error.
Ventilation Updates
For Trilogy Evo and Trilogy Evo O2 Ventilators:
- Consult the patient’s health care professional before using noninvasive ventilation if the patient has specific conditions listed.
- All current users will receive the Clinical and Caregiver Manual Addendum (Ref. 1147302).
- New devices will be supplied with Instructions for Use (Ref. 1146290 & Ref. 1146291) and the Clinical and Caregiver Manual Addendum (Ref. 1147302).
FAQ
Q: Where can I find more information?
A: For more information, visit philips.com/SRC-
update.
We are committed to supporting clinicians through the correction* process and will provide resources to help you better inform, instruct, and support your patients. This bulletin was created to help address common questions and concerns as well as provide a status update on correction efforts as they become available. Please find updates below.
Sleep Updates
First-generation DreamStation Device Testing Error
You may have read about an issue where a limited number of first-generation
DreamStation devices exhibited a device testing error prior to shipping. This
issue does not affect DreamStation devices in Australia or New Zealand and no
action is required here.
Ventilation Updates
Trilogy Evo Instructions for Use
During an internal review of the Trilogy Evo and Trilogy Evo O2 Ventilators
Instructions for Use (IFU) manuals, Philips Respironics determined that the
Contraindications Statement was incomplete. The following contraindications
apply to the Trilogy Evo and Trilogy Evo O2 Ventilators:
Instructions for Use Contraindications:
If the patient has any of the following conditions, consult the patient’s
health care professional before using noninvasive ventilation:
- An inability to maintain a patent airway or adequately clear secretions
- At risk of aspirating gastric contents
- Acute sinusitis or otitis media
- Epistaxis, causing pulmonary aspiration of blood
- Hypotension
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. The contraindications listed above in bold, are either omitted or listed in other locations within the IFU manuals.
The updated Contraindications in the Clinical and Caregiver Manual Addendum are as follows:
Contraindications
If the patient has any of the following conditions, consult the patient’s
health care professional before using noninvasive ventilation:
- An inability to maintain a patent airway or adequately clear secretions
- At risk of aspirating gastric contents
- Acute sinusitis or otitis media
- Epistaxis, causing pulmonary aspiration of blood
- Hypotension
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.
Note : The AVAPS-AE therapy mode and the AVAPS feature are not available
for Trilogy Evo Universal devices. The Clinical and Caregiver Manual Addendum
(Ref. 1147302) will be sent to customers to provide to all current users. All
new devices will be supplied with the Instructions for Use (Ref. 1146290 &
Ref. 1146291) and the Clinical and Caregiver Manual Addendum (Ref. 1147302).
Useful Links
-
*PE-PUR Foam Product Correction News and Updates for Clinicians**
Be sure to visit our Australian clinicians information page regularly for the most current information for you and your patients.
Patients may still have questions about the correction process or may need additional support once they have received their replacement device. We have recently created our Contact and Support page to help patients quickly and easily find the support they need. -
Masks and Magnets Updates
Do you have additional questions about Philips Respironics masks and magnets? Learn more, here. -
Ventilation Updates
For the latest ventilation news and updates, please visit this page.
For more information, visit philips.com/SRC-update.
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Urgent Product Defect Correction in Australia and Recall for Product
Correction in New Zealand.