Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800,

FDA device recall Z-0883-2023 · posted 2023-01-06 · Open, Classified

Recall details

Recalling firm

Philips Respironics, Inc.

Reason for recall

The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

Action taken

Telephone calls and URGENT Medical Device Recall notification letters were distributed beginning 12/6/22. Actions you must take as a device owner or healthcare provider to prevent risks for patients. Device is on patients: For affected Trilogy 100 and Trilogy 200 devices that are on patients, ensure that your clinical assessment of the patients is up to date, reflecting the true acuity of the patients and their respiratory therapy requirements. Your patient may experience serious harm if their device malfunctions and immediate intervention is not available. Until Philips Respironics is able to correct this problem you must adhere to the instructions below. Further instructions are provided below for devices that are not on patients. For ventilator dependent patients: 1. Consider transitioning ventilator dependent patients to an alternative life-support ventilator if, as determined by the clinical assessment for the individual patient in consultation with the patient s healthcare provider, a malfunction would lead to serious injury if timely access to a backup ventilator is not possible. 2. Quarantine all impacted devices that are removed from service. 3. Please indicate which Serial Numbers must be removed from service in exchange for an alternative device For all other patients: 1. Ensure that device alarm settings are configured appropriately for your patient s needs, with special consideration for the alarms listed below. Ensure that alternative ventilation equipment is available, as appropriate to patient need, in case of emergency issues with alarms that cannot be resolved. 2. Ensure that backup monitoring is configured as required by the clinical assessment. Pulse oximetry, ECG, heart rate, blood pressure, or respiratory rate may provide additional advanced warning of and lead to faster intervention if hypoxemia were to occur. If these accessories are prescribed, ensure patients advised of proper use. 3. Consider using an inline bacterial filter which ma

Root cause

Process design

Status

Open, Classified

Product code

CBK

Quantity affected

537 devices

Distribution

US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.

Date initiated

2022-12-07

Date posted

2023-01-06

Location

Murrysville, PA

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