BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3813567 · Received March 26, 2014

    Report

    Report Number
    2518422-2014-00514
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 26, 2014
    Report Date
    February 26, 2014
    Manufacturer
    RESPIRONIC, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE. WHEN THE SD CARD IS REMOVED FROM THE DEVICE, IT DOES NOT POWER OFF. WHEN THE SD CARD IS REMOVED, A PROMPT IS DISPLAYED ASKING THE USER IF THEY WOULD LIKE TO POWER THE DEVICE OFF, YES OR NO.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR POWERS ON WHEN THE SD CARD IS INSERTED AND POWERS OFF WHEN THE SD CARD IS REMOVED. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176785 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONIC, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1