BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4113639 · Received September 17, 2014

    Report

    Report Number
    2518422-2014-01575
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE DEVICE'S LCD DISPLAY SCREEN WAS BLANK. THE DEVICE'S LCD DISPLAY SCREEN WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE HAD PHYSICAL DAMAGE CONSISTENT WITH THE DEVICE BEING DROPPED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD PARTY SERVICE CENTER ALLEGING AN ISSUE WITH A VENTILATOR'S DISPLAY SCREEN. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576076 TRILOGY 100 CBK RESPIRONICS INC 1054097

    Patients

    Seq Age Sex Outcome Treatment
    1