BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOLOGY 202

    MDR report key: 3813499 · Received March 26, 2014

    Report

    Report Number
    2518422-2014-00486
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SOFTWARE WAS RELOADED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFO ALLEGING A VENTILATOR WAS ALARMING FOR LOW OXYGEN FLOW. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176886 TRIOLOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040007

    Patients

    Seq Age Sex Outcome Treatment
    1