BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARBIN EVO, LINDE

    MDR report key: 20682134 · Received November 14, 2024

    Report

    Report Number
    2518422-2024-103886
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    October 30, 2024
    Report Date
    October 28, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959057432
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS ORIGINALLY REPORTED ON 14 NOVEMBER 2024 THAT THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED ON A TRILOGY EVO VENTILATOR AND THERE WAS NO HARM OR INJURY REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE HAD NOT YET BEEN RETURNED TO THE MANUFACTURER AND AT THAT TIME, WE WERE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. FURTHER INVESTIGATION INTO THIS COMPLAINT HAS DETERMINED THAT THIS DEVICE ISSUE HAD BEEN PREVIOUSLY REPORTED ON EMDR 2518422-2024-101718 AND 2518422-2024-101718-1. THIS COMPLAINT RECORD (2518422-2024-103886) IS CONFIRMED TO BE A DUPLICATE COMPLAINT. PLEASE CLOSE THIS RECORD AS A DUPLICATE OF THE AFOREMENTIONED EMDR REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR INOPERATIVE CONDITION OCCURRED. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. 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
    1195256 GARBIN EVO, LINDE VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. LD2110X23B 00606959057432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown