BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2850197 · Received November 21, 2012

    Report

    Report Number
    2518422-2012-02316
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT A THIRD PARTY SVC CTR, AN ISSUE RELATED TO THE DEVICE'S SENSOR BOARD WAS OBSERVED. THE VENTILATOR'S SENSOR BOARD WAS REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR FAILED A CHECKOUT TEST DURING MAINTENANCE AT A THIRD PARTY SERVICE CENTER. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1