BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4127645 · Received September 24, 2014

    Report

    Report Number
    2518422-2014-01676
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 30, 2014
    Report Date
    August 30, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILS TO ALLOW A CIRCUIT CHOICE OIF PASSIVE VERSUS ACTIVE. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593425 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1