BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 3070247 · Received April 16, 2013

    Report

    Report Number
    2518422-2013-00624
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 18, 2013
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR WOULD NOT POWER ON. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS YET TO BE RETURNED TO THE MFR FOR EVAL. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164018 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE. CBK RESPIRONICS INC 104000

    Patients

    Seq Age Sex Outcome Treatment
    1