BEUDAMED
    FDA Recall Open, Classified

    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B

    Recall: Z-1287-2023 · Initiated March 1, 2023

    Recall

    Recall Number
    Z-1287-2023
    Event Number
    91832
    Firm
    Philips Respironics, Inc.
    FEI Number
    2518422
    Product Code
    CBK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 1, 2023
    Posted
    April 3, 2023
    Address
    1001 Murry Ridge Ln, Murrysville, PA, 15668-8517

    Description

    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, BL2100X15B, GB2100X15B, EU2100X15B, EU2100X19, EE2100X15B, TR2100X15B, UDS2100X11B, RDS2100X11B, and SP2100X26B

    Reason

    The 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 lead to under delivery of oxygen.

    Action

    An URGENT Medical Device Correction notification letter dated 3/1/23 was sent to customers. Actions that should be taken by the user in order to prevent risks for patients. Until a solution is provided by Philips Respironics, patients prescribed Trilogy EV300, Trilogy Evo O2, or Trilogy Evo Universal that use high pressure oxygen, the following precautions must be observed: 1. Continuously monitor oximetry (SpO2) of the patient and follow your institution s protocol for monitoring of arterial blood gas measurements to ensure that the patient is receiving adequate oxygenation. 2. Use an external FiO2 monitor for any patient requiring FiO2 e70% to identify under delivery of oxygen. Switch to an alternative ventilator if an external FiO2 monitor is not available. 3. Maintain an immediately available back up device that will allow rapid transition to a different oxygen delivery method or alternative ventilator if monitoring suggests FiO2 is not being sufficiently delivered. Distribute this notice to all employees in your organization that need to be aware. Actions planned by Philips Respironics to correct the problem. Philips Respironics will release a software update that will address the issue. This software will be available free of charge to all Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal users. Additional details will be provided when the update is available. In the interim, please take the actions above in order to prevent risk for your patients. If you need any further information or support concerning this issue, please contact your local Philips representative or Philips Respironics Customer Service at 1 (800) 345 6443.

    Distribution

    Worldwide distribution. US Nationwide including Puerto Rico, and countries of AE, AR, AT, AU, BD, BE, BG, BO, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GE, GT, HK, HR, HU, ID, IL, IE, IN, IT, JP, KW, LB, LT, MM, MQ, MX, MY, NG, NL, NO, NP, NZ, PE, PF, PH, PK, PL, PT, QA, RO, RS, RU, SA, SG, SI, SK, TH, TR, TW, UA, VN, and ZA.

    Quantity

    62,826 total devices