BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3030676 · Received March 27, 2013

    Report

    Report Number
    2518422-2013-00453
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFG'S SERVICE CTR, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S INTERNAL BATTERY WILL BE REPLACED TO ADDRESS THE ISSUE. DEVICE HAS BEEN EVALUATED BUT NOT REPAIRED, PENDING CUSTOMER APPROVAL OF THE ESTIMATE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SERVICE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO PT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125388 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1