BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 202

    MDR report key: 13011559 · Received December 15, 2021

    Report

    Report Number
    2518422-2021-08231
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 23, 2021
    Report Date
    July 20, 2022
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    UDI-DI
    00606959005150
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR WAS ALARMING FOR A HIGH INTERNAL OXYGEN ALARM CONDITION. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S OXYGEN BLENDING MODULE BOARD WAS REPLACED TO ADDRESS THE ISSUE. THIS ISSUE WAS ALSO REPORTED TO THE FDA ON MDR 2518422-2021-08288-1 DUE TO THE SERIAL NUMBER NOT BEING PROVIDED INITIALLY.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WAS ALARMING FOR A HIGH INTERNAL OXYGEN ALARM CONDITION. 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
    1908624 TRILOGY 202 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1040007 00606959005150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown