BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY100 VENTILATOR

    MDR report key: 18949536 · Received March 21, 2024

    Report

    Report Number
    2518422-2024-14636
    Event Type
    Malfunction
    Date Received
    March 21, 2024
    Date of Event
    March 6, 2024
    Report Date
    August 9, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959025387
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED RECEIVING INFORMATION ALLEGING A VENTILATOR FAILED THE POST FCO INSTALLATION TESTS. DURING THE SUBSEQUENT EVALUATION IT WAS DETERMINED BY THE SITE ENGINEER THAT THE ACTIVE EXHALATION CONTROL (AECM) MODULE FAILED. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTIONS WERE SPECIFIED. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER¿S COMPLAINT WAS CONFIRMED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR FAILED THE POST FCO INSTALLATION TESTS. DURING THE SUBSEQUENT EVALUATION IT WAS DETERMINED BY THE SITE ENGINEER THAT THE ACTIVE EXHALATION CONTROL (AECM) MODULE FAILED. THERE WAS NO HARM OR INJURY REPORTED. NO MEDICAL INTERVENTIONS WERE SPECIFIED. THE DEVICE HAS NOT 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
    1926469 TRILOGY100 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054655 00606959025387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown