BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EV300

    MDR report key: 13454806 · Received February 4, 2022

    Report

    Report Number
    2518422-2022-03302
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 7, 2022
    Report Date
    May 4, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959052017
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS INITIALLY REPORTED, THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S OXYGEN SENSOR WOULD NOT CALIBRATE. 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, OXYGEN SENSOR AND OXYGEN SENSOR CABLE WERE REPLACED TO ADDRESS THE ISSUE. THE SYSTEM BOARD WAS NOT REPLACED.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. UPON FURTHER REVIEW, THIS DEVICE WAS A REPAIRED DEVICE AND DID NOT CONTAIN SOUND ABATEMENT FOAM THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY AND IS NOT IN SCOPE OF RES 88058. THEREFORE, THERE IS NO ALLEGATION OF A REPORTABLE EVENT ASSOCIATED WITH THE DEVICE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS DEVICE ON MDR 2518422-2022-03302-2. PLEASE DISREGARD MDR 2518422-2022-03302-2 AS IT WAS FILED IN ERROR.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S OXYGEN SENSOR WOULD NOT CALIBRATE. 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, OXYGEN SENSOR AND OXYGEN SENSOR CABLE WERE REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987583 TRILOGY EV300 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2200X11B 00606959052017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown