BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 15672091 · Received October 26, 2022

    Report

    Report Number
    2518422-2022-87921
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    October 6, 2022
    Report Date
    February 12, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959025394
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE. THE PRODUCT INVESTIGATION LABORATORY INVESTIGATED THE SD CARD, FRONT PANEL PCA, AND SYSTEM BOARD RECEIVED FOR INVESTIGATION. DURING THE INVESTIGATION, WE CONFIRMED THE COMPLAINT OF SD CARD FAILURE. THE SYSTEM BOARD APPEARS TO HAVE NO PROBLEMS FOUND (NPF), PASSING ALL TESTS. THE FRONT PANEL PCA APPEARS TO WORK AS DESIGNED; NO PROBLEM WAS FOUND, PASSING ALL TESTS. THE MICRON SD CARD S/N (B)(6) THAT WAS SENT APPEARS TO BE FAULTY OR DAMAGED, CAUSING AN SD FAULT IN THE COMPLAINT. THE SYSTEM BOARD APPEARS TO ACCEPT AND READ A KNOWN-GOOD SD CARD WITHOUT ISSUE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD NEEDS TO BE REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2776074 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040004 00606959025394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown