BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300

    MDR report key: 19405455 · Received May 28, 2024

    Report

    Report Number
    2518422-2024-31773
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    May 10, 2024
    Report Date
    November 15, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING AN ERROR CONCERNING THE BATTERY OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS EVALUATED BY A FIELD SERVICE ENGINEER, AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. ERROR 59 WAS FOUND IN EVENT LOG AND ADVISED CUSTOMER TO TEST INTERNAL AND DETACHABLE BATTERIES VIA SD+T ASSESSMENT TOOL AND VERIFY IF BATTERIES ARE CHARGING WHEN PLUGGED INTO AC POWER, CUSTOMER VERIFIED BATTERY ASSESSMENT PASSED IN SD+T TOOL AND APPEARS TO BE CHARGING CORRECTLY. CUSTOMER ADVISED THAT DIFFERENT KNOWN GOOD BATTERIES WERE TRIED BUT PROBLEM PERSISTS, REQUESTS BENCH REPAIR, EMAILED BENCH REPAIR FORM TO CUSTOMER WITH INSTRUCTIONS.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ERROR CONCERNING THE BATTERY OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677612 TRILOGY EV300 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown