BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 3040498 · Received February 14, 2013

    Report

    Report Number
    2518422-2013-00166
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    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 EVALUATION OF THE DEVICE AT THE MFR'S SERVICE CENTER, A "SERVICE REQUIRED" CODE WAS FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE WAS PUT IN TO "SLEEP" MODE AND REBOOTED TO CLEAR THE "SERVICE REQUIRED" CODE. THE DEVICE PASSED ALL TESTING AND REQUIRED NO REPLACEMENT OF COMPONENTS TO ADDRESS THE ISSUE. THE VENTILATOR WAS FURTHER EVALUATED AT THE MFR'S QUALITY ASSURANCE LAB. THE DEVICE PASSED ALL TESTING AND WAS FOUND TO OPERATE AS DESIGNED. NO MALFUNCTION WAS OBSERVED. 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 (B)(4).

    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
    66236 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1