BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3012829 · Received February 5, 2013

    Report

    Report Number
    2518422-2013-00147
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S INLET AIR PATH ASSEMBLY FOAM HAD BECOME SEPARATED FROM THE HOUSING, PARTIALLY OCCLUDING THE BLOWER INLET. THE INLET AIR PATH ASSEMBLY FOAM WAS REPLACED TO CORRECT THE PROBLEM.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49937 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1