BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3001773 · Received January 15, 2013

    Report

    Report Number
    2518422-2013-00061
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 27, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, THE DEVICE FAILED A STEP DURING TESTING. THE FAILURE APPEARS TO BE CAUSED BY CONTAMINATION FOUND WITHIN THE DEVICE. THE DEVICE'S SENSOR BOARD WILL BE REPLACED TO ADDRESS THE ISSUE. DEVICE HAS BEEN EVALUATED BUT THE COMPONENTS HAVE NOT BEEN REPLACED PENDING CUSTOMER APPROVAL OF THE ESTIMATE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SERVICE. THERE WAS NO HARM OR INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22526 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1