BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY O2

    MDR report key: 3982949 · Received July 2, 2014

    Report

    Report Number
    2518422-2014-01093
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 9, 2014
    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

    THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S SYSTEM BOARD WILL BE REPLACED TO ADDRESS THE ISSUE. CONCLUSIONS: THE DEVICE WAS EVALUATED, BUT NOT YET REPAIRED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD NOT POWER ON. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388192 TRILOGY O2 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC., 1040004

    Patients

    Seq Age Sex Outcome Treatment
    1