BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3023190 · Received February 27, 2013

    Report

    Report Number
    2518422-2013-00334
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE INCREASED AIRSTREAM TEMP (HIGH TEMP ALARM) APPEARS TO HAVE BEEN CAUSED BY THE AMBIENT CONDITIONS IN WHICH THE DEVICE WAS OPERATING. NO MALFUNCTIONS WERE NOTED. THE DEVICE WAS FOUND TO AUDIBLY AND VISUALLY ALARM, AS DESIGNED.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A HIGH TEMP ALARM OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84777 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1