BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 02

    MDR report key: 3851032 · Received February 12, 2014

    Report

    Report Number
    2518422-2014-00207
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. DURING THE EVAL, THE DEVICE FAILED STEPS DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93611 TRILOGY 02 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1