BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3111623 · Received May 6, 2013

    Report

    Report Number
    2518422-2013-00748
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING EVALUATION OF THE VENTILATOR AT THE MANUFACTURER'S SERVICE CENTER THE DEVICE FAILED A TEST STEP. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WILL BE REPLACED TO ADDRESS THE ISSUE. CONCLUSIONS = DEVICE HAS BEEN EVALUATION BUT THE COMPONENTS HAVE NOT BEEN REPLACED PENDING CUSTOMER APPROVAL OF ESTIMATE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197594 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1