BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 10243071 · Received July 7, 2020

    Report

    Report Number
    2518422-2020-01554
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 26, 2020
    Report Date
    June 26, 2020
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    PMA / PMN Number
    K181166
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 A CORRECTION TO MDR (B)(4) AS BEING FILED WITH THE INCORRECT 510K NUMBER ON MDR (B)(4). MDR (B)(4) WAS FILED CORRECTLY WITH THE CORRECT 510K NUMBER. MDR 2518422-2020-01555 WAS THE REPORT THAT CONTAINS THE INCORRECT 510K NUMBER. A CORRECTED REPORT HAS BEEN FILED WITH THE CORRECT 510K NUMBER AND IS REPORT MDR 2518422-2020-01555-1.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR EVALUATION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT A THIRD PARTY SERVICE CENTER, AN ISSUE RELATED TO THE ACTIVE EXHALATION CONTROL MODULE WAS OBSERVED. THE DEVICE'S ACTIVE EXHALATION CONTROL MODULE WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705776 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1