BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3142687 · Received May 24, 2013

    Report

    Report Number
    2518422-2013-00950
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SENSOR BOARD WAS REPLACED TO ADDRESS THE ISSUE. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A HIGH TEMPERATURE ALARM WAS OBSERVED AND THE DEVICE DOWNLOADED EVENT LOG. THE INCREASED AIRSTREAM TEMPERATURE (HIGH TEMPERATURE ALARM) APPEARS TO HAVE BEEN CAUSED BY THE AMBIENT CONDITIONS IN WHICH THE DEVICE WAS OPERATING. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE FAILED AT TEST STEP, THE DEVICE ACTIVE EXHALATION CONTROL MODULE 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 MANUFACTURER'S UPDATED REPORTING PROCEDURES. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER 12-PHI-01.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION THAT THE VENTILATOR WOULD NOT CYCLE. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232399 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1