BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILLOGY 100

    MDR report key: 11019829 · Received December 16, 2020

    Report

    Report Number
    2518422-2020-03026
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    December 7, 2020
    Report Date
    January 8, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CBK
    UDI-DI
    00606959026469
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER REPORTED THE INCORRECT DATE OF 12-16-2929 IN SECTION B4 ON MDR. THE CORRECT DATE FOR SECTION B4 IS 12-16-2020.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488515 TRILLOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS INC. 1054096B 00606959026469

    Patients

    Seq Age Sex Outcome Treatment
    1