Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
Recall
- Recall Number
- Z-0785-2022
- Event Number
- 89584
- Firm
- Philips Respironics, Inc.
- FEI Number
- 2518422
- Product Code
- CBK
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- June 12, 2018
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8517
Description
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.
In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles. This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices. A Field Communication for Trilogy Preventive Maintenance Update was distributed to customers 6/12/18. PRODUCT(S) AFFECTED All Trilogy models with Inlet Air Path Assembly PURPOSE / SCOPE This Field Communication announces: " The addition of the replacement of the Inlet Air Path Assembly and Removable Air Path Foam during the 10000 blower hour/24 month (whichever comes first) PM and 17,500-blower hour PM interval. " Trilogy Ventilator Maintenance Record revision to include the replacement date for the Air Inlet Path Assembly and Removable Air Path Foam. ACTION REQUIRED At both the 10000 blower hour/24 month (whichever comes first) and 17,500-blower hour PM intervals, the Inlet Air Path Assembly and Removable Air Path Foam are to be replaced. PROCEDURE For Inlet Air Path Assembly replacement procedures, refer to the Trilogy 100, 200, 202 & O2 Service & Technical Information Manual P/N 1002735 Section 11.2.3. For Removable Air Path Foam replacement procedures, refer to the Trilogy 100, 200, 202 & O2 Service & Technical Information Manual P/N 1002735 Section 11.2.4. IF you have any questions contact: Customer Service and Technical Support at 1-800-345-6443 or 724-387-4000 or email technical support at [email protected].
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