BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY100 VENTILATOR

    MDR report key: 18720752 · Received February 16, 2024

    Report

    Report Number
    2518422-2024-07882
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Date of Event
    December 14, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959025387
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR REQUIRED PERIODIC MAINTENANCE. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTIONS WERE SPECIFIED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE ACTIVE EXHALATION CONTROL MODULE (AECM) WAS FOUND TO BE MALFUNCTIONING. THE AECM, EXHAUST FAN, 43 MICRON FILTER WERE REPLACED,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424920 TRILOGY100 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. R1054655TP 00606959025387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown