BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 10277769 · Received July 15, 2020

    Report

    Report Number
    2518422-2020-01580
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 19, 2020
    Report Date
    June 19, 2020
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THE INCORRECT 510K NUMBER AS K18166. THE CORRECT 510K NUMBER IS K181166 AND IS REFLECTED IN G5.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THAT THE 510K NUMBER WAS INCORRECT ON THE ORIGINAL SUBMISSION REPORT MDR (B)(4) AND FILED A CORRECTED FOLLOW UP, MDR (B)(4). THE ORIGINGAL REPORT DID CONTAIN THE CORRECT 510K NUMBER AS K181166, NO CORRECTED REPORT NEEDED TO BE FILED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR "SERVICE REQUIRED" ALARM CONDITION OCCURRED . 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 OXYGEN BLENDING MODULE ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743287 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. SP2100X26B

    Patients

    Seq Age Sex Outcome Treatment
    1