BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 11706531 · Received April 22, 2021

    Report

    Report Number
    2518422-2021-01102
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    April 13, 2021
    Report Date
    June 8, 2021
    Manufacturer
    PHILIPS RESPIRONICS INC.
    Product Code
    CBK
    UDI-DI
    00606959015364
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED IN SECTION B4 AS THE DATE OF THE REPORT AS 04/21/2021. THE CORRECT DATE OF THE REPORT AS 04/22/2021.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED A VENTILATOR ALLEGEDLY HAVING A DEPLETED INTERNAL BATTERY AND THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE WAS NOT IN PATIENT USE. THE MANUFACTURER CONFIRMS THE INTERNAL BATTERY WAS NOT REPLACED AND THE DEVICE WAS RETURNED UNREPAIRED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE INTERNAL BATTERY WAS DEPLETED ON A VENTILATOR. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607851 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS RESPIRONICS INC. 1054260 00606959015364

    Patients

    Seq Age Sex Outcome Treatment
    1