BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 6200627 · Received December 22, 2016

    Report

    Report Number
    2518422-2016-04951
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    December 6, 2016
    Report Date
    December 6, 2016
    Manufacturer
    RESPIRONICS, INC
    Product Code
    CBK
    UDI-DI
    00606959033887
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER PREVIOUSLY REPORTED A FAILURE OF THE AC POWER CORD. THE AC POWER CORD WAS RETURNED TO THE MANUFACTURER'S QUALITY ASSURANCE LABORATORY FOR FURTHER INVESTIGATION. DURING THE INVESTIGATION, THE ROOT CAUSE OF THE AC POWER CORD FAILING WAS FOUND TO BE CAUSED BY AN OPEN CONDITION.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PATIENT USE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN OPEN CONDITION WAS FOUND WITHIN THE DEVICE'S POWER CORD. THE DEVICE'S POWER CORD WAS REPLACED TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848954 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC 1040004 00606959033887

    Patients

    Seq Age Sex Outcome Treatment
    1