BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4850335 · Received June 17, 2015

    Report

    Report Number
    2518422-2015-01720
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    PHILIPS RESPIRONICS
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS FOUND TO BE DAMAGED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394994 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1