BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 3871218 · Received April 16, 2014

    Report

    Report Number
    2518422-2014-00614
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 26, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE LCD DISPLAY CABLE WAS FOUND TO BE LOOSE. THE LCD DISPLAY CABLE WAS RECONNECTED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING A VENTILATOR'S LCD DISPLAY SCREEN WAS BLANK. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233649 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1040000

    Patients

    Seq Age Sex Outcome Treatment
    1