BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY100

    MDR report key: 3022955 · Received March 20, 2013

    Report

    Report Number
    2518422-2013-00432
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, AN ODOR WAS DETECTED EMANATING FROM THE POWER SUPPLY. THE TECH COULD NOT FIND ANY PROBLEMS WITH THE UNIT. THE DEVICE'S POWER SUPPLY WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFORMATION ALLEGING SMOKE WAS OBSERVED COMING OUT OF THE BACK OF THE VENTILATOR. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116755 TRILOGY100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1