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Class 1 Device Recall Philips Trilogy 200 Ventilator |
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Date Initiated by Firm |
December 07, 2022 |
Date Posted |
January 06, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0883-2023 |
Recall Event ID |
91293 |
510(K)Number |
K093416
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Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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Product |
Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B
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Code Information |
UDI: 00606959429154
00606959429208
00606959429147
00606959429185
00606959429710
00606959429611
00606959429475
00606959429260
00606959033986
00606959033993
00606959429444;
Serial Numbers: TV212103056
TV213062024
TV214101606
TV210092113
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TV212062653
TV212041012 |
Recalling Firm/ Manufacturer |
Philips Respironics, Inc. 1001 Murry Ridge Ln Murrysville PA 15668-8517
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For Additional Information Contact |
Philips Customer Service 800-345-6443
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Manufacturer 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.
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FDA Determined Cause 2 |
Process design |
Action |
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 |
Quantity in Commerce |
537 devices |
Distribution |
US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = CBK and Original Applicant = RESPIRONICS, INC.
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