BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 02

    MDR report key: 3131222 · Received May 23, 2013

    Report

    Report Number
    2518422-2013-00937
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K093905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SVC CENTER, ISSUES RELATED TO THE SENSOR BOARD AND ACTIVE EXHALATION CONTROL MODULE WERE FOUND. THE DEVICE'S SENSOR BOARD AND ACTIVE EXHALATION CONTROL MODULE WERE REPLACED TO ADDRESS THE ISSUES. THIS REPORT IS BEING SUBMITTED AS PART OF A PROGRAM TO RETROSPECTIVELY REVIEW POSSIBLE DEVICE MALFUNCTIONS THAT DID NOT INVOLVE ANY INJURY, TO DETERMINE WHETHER THEY ARE REPORTABLE UNDER 21 CFR PART 803 AND THE MFR'S UPDATED REPORTING PROCEDURES. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER 12-PHI-01.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SVC. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228544 TRILOGY 02 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1