BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 11849924 · Received May 19, 2021

    Report

    Report Number
    2518422-2021-01414
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 19, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745312 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1