BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 14573614 · Received June 2, 2022

    Report

    Report Number
    2518422-2022-28760
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 3, 2022
    Report Date
    September 20, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959051942
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR'S PEAK INSPIRATORY PRESSURE WAS OUT OF RANGE. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUS REPORT SECTION H10 WAS INCORRECTLY CAPTURED, IT SHOULD HAVE BEEN REPORTED AS: THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S PEAK INSPIRATORY PRESSURE WAS OUT OF RANGE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. PIL VISUALLY INSPECTED THE SUSPECT COMPONENT FOR OBVIOUS DEFECTS AND FOUND NONE. PIL DOWNLOADED AND REVIEWED THE ORIGINAL DEVICE ERROR LOG AND FOUND 0 INSTANCES OF E-110 ERRORS. PIL REFERRED TO THE TRILOGY DEFECT INVESTIGATION PROCEDURE, ER 1101979, VER. 09 REGARDING THIS ERROR AND FOUND THE FOLLOWING INFORMATION E-110 ERROR CODE DESCRIPTION; EVT_MOTOR_SHUTDOWN. PIL CONCLUDES THE COMPONENT OPERATES PROPERLY HOWEVER THIS FAILURE MODE IS BEING INVESTIGATED UNDER CAPA 2548468. PRODUCT INVESTIGATION LAB (PIL) WAS UNABLE TO CONFIRM THE ALLEGED FAILURE OF THE TRILOGY EVO SYSTEM PCA. VISUAL INSPECTION FOUND NO DEFECTS. PIL INSTALLED THE SUSPECT COMPONENT INTO THE PIL TRILOGY EVO TEST BED, RAN THE DEVICE NO E-110 NOR ANY UNEXPECTED ERRORS WERE GENERATED. PIL CONCLUDES THE COMPONENT OPERATES PROPERLY HOWEVER THIS FAILURE MODE IS BEING INVESTIGATED UNDER CAPA 2548468.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING AN VISUALIZATION OF PARTICLES IN THE AIR PATH RELATED TO A VENTILATOR'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. PIL VISUALLY INSPECTED THE SUSPECT COMPONENT FOR OBVIOUS DEFECTS AND FOUND NONE. PIL DOWNLOADED AND REVIEWED THE ORIGINAL DEVICE ERROR LOG AND FOUND 0 INSTANCES OF E-110 ERRORS. PIL REFERRED TO THE TRILOGY DEFECT INVESTIGATION PROCEDURE, ER 1101979, VER. 09 REGARDING THIS ERROR AND FOUND THE FOLLOWING INFORMATION E-110 ERROR CODE DESCRIPTION; EVT_MOTOR_SHUTDOWN. PIL CONCLUDES THE COMPONENT OPERATES PROPERLY HOWEVER THIS FAILURE MODE IS BEING INVESTIGATED UNDER CAPA 2548468. PRODUCT INVESTIGATION LAB (PIL) WAS UNABLE TO CONFIRM THE ALLEGED FAILURE OF THE TRILOGY EVO SYSTEM PCA. VISUAL INSPECTION FOUND NO DEFECTS. PIL INSTALLED THE SUSPECT COMPONENT INTO THE PIL TRILOGY EVO TEST BED, RAN THE DEVICE NO E-110 NOR ANY UNEXPECTED ERRORS WERE GENERATED. PIL CONCLUDES THE COMPONENT OPERATES PROPERLY HOWEVER THIS FAILURE MODE IS BEING INVESTIGATED UNDER CAPA 2548468. UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S PEAK INSPIRATORY PRESSURE WAS OUT OF RANGE. 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
    154871 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. DS2110X11B 00606959051942

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown