BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4973381 · Received August 5, 2015

    Report

    Report Number
    2518422-2015-02299
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 10, 2015
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED A FAILURE OF THE SYSTEM BOARD. THE SYSTEM BOARD WAS RETURNED TO THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION, THE ROOT CAUSE OF THE SYSTEM BOARD FAILING WAS DUE TO A PROGRAM CORRUPTION OF THE U3 FLASH.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS NOT FUNCTIONING PROPERLY. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, A FAILURE OF THE SYSTEM BOARD WAS OBSERVED. THE DEVICE'S SYSTEM BOARD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515559 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1