BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 18397152 · Received December 27, 2023

    Report

    Report Number
    2518422-2023-37929
    Event Type
    Malfunction
    Date Received
    December 27, 2023
    Date of Event
    December 6, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026353
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 100 VENTILATOR DEVICE DID NOT MEET ACCEPTANCE CRITERIA OF EVALUATION PROCESS FOR THE FOLLOWING CONDITIONS: CRITICAL ERROR CODES 193, 290. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE TRILOGY 100 VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE DEVICE POWERED ON AND OPERATED AS IT SHOULD. ERROR CODE E-193 AND E-290 WERE CONFIRMED. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. ERRORS CLEARED AFTER THE INTERNAL BATTERY WAS REPLACED. THE INLET AIR PATH ASSEMBLY AND REMOVABLE AIR PATH FOAM WAS REPLACED PER REMEDIATION. THE DEVICE PASSED ALL TESTING.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A TRILOGY 100 VENTILATOR DEVICE DID NOT MEET ACCEPTANCE CRITERIA OF EVALUATION PROCESS FOR THE FOLLOWING CONDITIONS: CRITICAL ERROR CODES 193, 290. THERE WAS NO HARM OR INJURY REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. 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
    2291897 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260B 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown