BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 2860583 · Received December 5, 2012

    Report

    Report Number
    2518422-2012-02363
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A HIGH TEMPERATURE ALARM CONDITION WAS OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE INCREASED AIRSTREAM TEMPERATURE (HIGH TEMPERATURE ALARM) APPEARS TO HAVE BEEN CAUSED BY THE AMBIENT CONDITIONS IN WHICH THE DEVICE WAS OPERATING.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1040000

    Patients

    Seq Age Sex Outcome Treatment
    1