BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 2891405 · Received December 26, 2012

    Report

    Report Number
    2518422-2012-02506
    Event Type
    Malfunction
    Date Received
    December 26, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE TECHNICIAN FOUND THE INTERNAL BATTERIES NOT CHARGING. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION 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
    1 TRILOGY 200 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1032802

    Patients

    Seq Age Sex Outcome Treatment
    1