BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 2894475 · Received December 27, 2012

    Report

    Report Number
    2518422-2012-02499
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR¿S SERVICE CENTER, A ¿SERVICE REQUIRED¿ CODE WAS FOUND IN THE VENTILATOR¿S DOWNLOADED ERROR LOG AND THE DEVICE FAILED A STEP DURING TESTING. THE DEVICE¿S SYSTEM BOARD AND SENSOR BOARD WILL BE REPLACED TO ADDRESS THE ISSUES. 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 HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP 1054096

    Patients

    Seq Age Sex Outcome Treatment
    1