BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 18484572 · Received January 10, 2024

    Report

    Report Number
    2518422-2024-01681
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    August 21, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959051942
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE TRILOGY EVO WAS SENT TO A THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE CUSTOMER COMPLAINT WAS REPRODUCED. EVALUTION NOTES: DEVICE AIR PRESSURE FAILURE, CONTAMINATION IN BLOWER AND MACHINE FLOW DAMAGE AND CONTAMINATION WERE FOUND. ERROR CODES E-0019, E-0022, E-0023, E-0024, E-0041, E-0042, E-0050, E-0063, E-0108, E-0136, E-0137, E-0139, E-0191, 0192, E-0233, E-0307, E-0350, E-0353 AND E-0359 WERE ALL NOTED IN THE ERROR LOG . THE FOLLOWING PARTS WERE REPLACED DUE TO CONTAMINATION OR COSMETIC ISSUES 1135214, RP- TRILOGY EVO BLOWER ASSEMBLY - CONTAMINATED 1135215, RP - TRILOGY EVO BLOWER BELLO WS SEAL - CONTAMINATED (1 PIECE) 1135216, RP - TRILOGY BLOWER MOUNT (10 PK) - CONTAMINATED (4 PIECES)1135223, RP - TRILOGY EVO INTERNAL BATTERY DOOR - CRACKS1135232, RP - TRILOGY EVO BASE ASSEMBLY - DAMAGE1135249, RP - TRILOGY EVO MACHINE FLOW SENSOR - CONTAMINATED1135257, RP - TRILOGY EVO MUFFLER ASSEMBLY - CONTAMINATED1135260, RP - TRILOGY EVO AIR INLET FOAM FILTER - MISSING 1140097, RP - TRILOGY EVO TUBING-SYSTEM PCA - CONTAMINATED1140101, RP -TRILOGY EVO TUBING-LOW FLOW O2 - CONTAMINATED SERIAL NUMBER LABEL NEEDS TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1032975 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2110X11B 00606959051942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown