BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 8883358 · Received August 12, 2019

    Report

    Report Number
    2518422-2019-01703
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 19, 2019
    Report Date
    July 19, 2019
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, ERROR CODES RELATED TO THE CHARGING OF THE INTERNAL BATTERY WERE OBSERVED. THE DEVICE'S INTERNAL BATTERY AND POWER MANAGEMENT BOARD WERE REPLACED TO ADDRESS THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678722 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1