BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4092852 · Received August 20, 2014

    Report

    Report Number
    2518422-2014-01433
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD PARTY SERVICE CENTER ALLEGING A VENTILATOR WOULD NOT POWER ON. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN EVALUATED BY THE MANUFACTURER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500775 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1