BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 3772177 · Received January 2, 2014

    Report

    Report Number
    2518422-2014-00025
    Event Type
    Malfunction
    Date Received
    January 2, 2014
    Date of Event
    December 6, 2013
    Report Date
    December 6, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO FROM A THIRD PARTY SERVICE CENTER ALLEGING A VENTILATOR FAILED A STEP DURING TESTING. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2662 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040000

    Patients

    Seq Age Sex Outcome Treatment
    1