BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2801111 · Received October 17, 2012

    Report

    Report Number
    2518422-2012-02115
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO MFR FOR EVAL AND A HIGH TEMPERATURE ALARM CONDITION WAS OBSERVED. THE HIGH TEMPERATURE ALARM WAS CAUSED BY CONTAMINATION WITHIN THE DEVICE. THE VENTILATOR'S BLOWER MOTOR AND STIRRING FAN WERE REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1