BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 2941132 · Received January 16, 2013

    Report

    Report Number
    2518422-2013-00058
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 25, 2012
    Report Date
    December 25, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25274 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1