BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 18673142 · Received February 8, 2024

    Report

    Report Number
    2518422-2024-06409
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    February 5, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959022706
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : 100048.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING EQUIPMENT FAILURE. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378248 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040000 00606959022706

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown