BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 200

    MDR report key: 2960957 · Received January 30, 2013

    Report

    Report Number
    2518422-2013-00117
    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
    K093416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S BLOWER MOTOR AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40093 TRILOGY 200 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040005

    Patients

    Seq Age Sex Outcome Treatment
    1