BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 11701995 · Received April 20, 2021

    Report

    Report Number
    MW5100912
    Event Type
    Malfunction
    Date Received
    April 20, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 19, 2021
    Manufacturer
    PHILLIPS / RESPIRONICS INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT DISCONNECTED FROM THE TRILOGY EVO AND THE VENT DID NOT ALARM FOR CIRCUIT DISCONNECT. WENT TO THE PATIENT'S HOME AND SWAPPED OUT THE VENT. ACCORDING TO MOM, NO HARM TO THE PATIENT. NO HARM TO PATIENT. RETURNING THE VENT FOR FURTHER EVALUATION. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590544 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILLIPS / RESPIRONICS INC. TRILOGY EVO

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR