BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 7005918 · Received November 7, 2017

    Report

    Report Number
    2518422-2017-02547
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 17, 2017
    Report Date
    October 17, 2017
    Manufacturer
    PHILIPS/RESPIRONICS, INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS BEEN EVALUATED BUT NOT YET REPAIRED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN INTERNAL BATTERY DEPLETED ALARM CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD AND POWER MANAGEMENT BOARD NEED TO BE REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786642 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS/RESPIRONICS, INC 1054655

    Patients

    Seq Age Sex Outcome Treatment
    1