BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 4113805 · Received September 17, 2014

    Report

    Report Number
    2518422-2014-01625
    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
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MFR'S SERVICE CTR, "SERVICE REQUIRED" CODES WERE OBSERVED IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S POWER MGMT BOARD WAS REPLACED TO ADDRESS THE ISSUES.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575802 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1