BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2960966 · Received January 30, 2013

    Report

    Report Number
    2518422-2013-00091
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFORMATION ALLEGING A VENTILATOR'S REMOTE ALARM CONNECTOR WAS BROKEN. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. THE VENTILATOR WAS RETURNED TO THE MFR FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S INTERFACE BOARD WAS REPLACED TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40189 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1