BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 4792003 · Received May 22, 2015

    Report

    Report Number
    2518422-2015-01470
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 7, 2015
    Report Date
    May 7, 2015
    Manufacturer
    PHILIPS RESPIRONICS
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR COULD NOT BE TAKEN OUT OF PASSIVE MODE. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE TUBING BETWEEN THE DEVICE'S PORTING BLOCK AND ACTIVE EXHALATION CONTROL MODULE WAS FOUND TO BE CONTAMINATED. THE TUBING WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333868 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS 1040007

    Patients

    Seq Age Sex Outcome Treatment
    1