BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4871376 · Received June 26, 2015

    Report

    Report Number
    2518422-2015-01813
    Event Type
    Malfunction
    Date Received
    June 26, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN EVALUATED BUT NOT REPAIRED, PENDING CUSTOMER APPROVAL OF THE ESTIMATE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. WATER INGRESS WAS OBSERVED. THE DEVICE'S FLOW SENSOR ASSEMBLY AND SENSOR BOARD WILL BE REPLACED TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415415 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1