BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3024934 · Received March 15, 2013

    Report

    Report Number
    2518422-2013-00423
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    RESPIRONICS,
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONTINUED. THE DEVICE'S AC INLET CONNECTOR WAS REPLACED TO ADDRESS THE ISSUE. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER 12-PHI-01.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR'S AC INLET CONNECTOR WAS DAMAGED. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110368 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1