BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3023192 · Received February 27, 2013

    Report

    Report Number
    2518422-2013-00360
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SVC CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SVC. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84674 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1