BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 3140058 · Received May 29, 2013

    Report

    Report Number
    2518422-2013-01001
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2013
    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 SERVICE CENTER, A VENTILATOR INOPERATIVE CODE WAS LOGGED IN THE DEVICE'S ERROR LOG. THE DEVICE'S BLOWER MOTOR WAS REPLACED TO ADDRESS THE ISSUE. 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

    THE MFR REC'D INFO ALLEGING A "SERVICE REQUIRED" ALARM CONDITION OCCURRED. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234541 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1