BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRILOGY 202

    MDR report key: 3063086 · Received April 12, 2013

    Report

    Report Number
    2518422-2013-00623
    Event Type
    Other
    Date Received
    April 12, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFORMATION ALLEGING A VENTILATOR STOPPED DELIVERING FLOW AND THE PT WAS MANUALLY VENTILATED. THERE WAS NO SERIOUS HARM OR INJURY REPORTED. THE MFR IS CURRENTLY INVESTIGATING THIS ISSUE. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157339 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1040007

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention