BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSA NXT CONSOLE (115-230V)

    MDR report key: 3963465 · Received May 30, 2014

    Report

    Report Number
    3006697299-2014-00042
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    INTEGRA LIFESCIENCES IRELAND LIMITED
    Product Code
    LFL
    PMA / PMN Number
    K081459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE PRODUCT ARRIVED AT THE INTEGRA SERVICE CENTER ON (B)(6) 2014 FOR REPAIR. NO OTHER INFORMATION PROVIDED. ON (B)(6) 2014, THE PRODUCT WAS EVALUATED AND IT WAS DISCOVERED THAT THE PUMP'S FLOW WAS DEFECTIVE AND NEEDED TO BE REPLACED. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2014, THE REPORTER PROVIDED THE FOLLOWING. THE PRODUCT PROBLEM HAPPENED DURING THE STARTING PROCESS. THE PUMP DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319808 CUSA NXT CONSOLE (115-230V) ULTRASOUND SURGICAL PRODUCTS LFL INTEGRA LIFESCIENCES IRELAND LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1