BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 5978249 · Received September 26, 2016

    Report

    Report Number
    2518422-2016-03944
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    September 2, 2016
    Report Date
    September 2, 2016
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    UDI-DI
    00606959005150
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED A FAILURE OF THE ACTIVE EXHALATION CONTROL MODULE, BLOWER MOTOR, SYSTEM BOARD AND OXYGEN BLENDING MODULE BOARD. THE ACTIVE EXHALATION CONTROL MODULE, BLOWER MOTOR, SYSTEM BOARD AND OXYGEN BLENDING MODULE BOARD WERE RETURNED TO THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION THE ROOT CAUSE OF THE ACTIVE EXHALATION CONTROL MODULE FAILING WAS DUE TO THE PROPORTIONAL VALVE NOT FULLY CLOSING. THE BLOWER MOTOR WAS EVALUATED BY THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY AND THE ROOT CAUSE OF THE BLOWER MOTOR FAILING WAS DUE TO SEIZED BEARINGS. THE OXYGEN BLENDING MODULE BOARD WAS EVALUATED BY THE MANUFACTURER'S QUALITY ASSURACE LABORATORY AND THE ROOT CAUSE OF THE OXYGEN BLENDING MODULE BOARD FAILING WAS DUE TO SENSOR (U29) BEING OUT OF TOLERANCE. THE SYSTEM BOARD WAS EVALUATED BY THE QUALITY ASSURANCE LABORATORY AND WAS FOUND TO OPERATE TO DESIGN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" AND "VENTILATOR INOPERATIVE" CODE WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD, BLOWER MOTOR AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUES. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE AND FLOW ELEMENT WERE REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627887 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1040007 00606959005150

    Patients

    Seq Age Sex Outcome Treatment
    1