BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3913077 · Received May 14, 2014

    Report

    Report Number
    2518422-2014-00800
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, A FAILURE RELATED TO THE REMOTE ALARM CONNECTOR WAS OBSERVED. THE DEVICE'S INTERFACE BOARD WILL BE REPLACED TO ADDRESS THE ISSUE. DEVICE HAS BEEN EVALUATED BUT NOT REPAIRED, PENDING CUSTOMER APPROVAL OF THE ESTIMATE.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION FROM A THIRD PARTY SERVICE CENTER ALLEGING AN ISSUE WITH A VENTILATOR'S REMOTE ALARM CONNECTOR. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288140 TRILOGY 100 VENTILATOR, CONTINUOUS,FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1