BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 3843453 · Received June 2, 2014

    Report

    Report Number
    0001811755-2014-02014
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 6, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    PMA / PMN Number
    K132671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BACKFLOW WAS NOT ABLE TO BE CONFIRMED BY A MANUFACTURER REPAIR TECHNICIAN THROUGH FUNCTIONAL EVALUATION. BASED ON THE IFU, THE NEPTUNE ROVER SHOULD NOT BE CONNECTED TO A BEAN BAG; THEREFORE, THE ROOT CAUSE WAS DETERMINED TO BE USER ERROR. THE DEVICE WAS SERVICED FOR PREVENTIVE MAINTENANCE BY A MANUFACTURER FIELD SERVICE REPRESENTATIVE AT THE USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE NEPTUNE 2 ROVER ULTRA DURING A PROCEDURE, FLUID STARTED TO BACKFLOW DOWN ONE OF THE SUCTION TUBES THAT WAS CONNECTED TO THE "BEAN BAG". THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING THE NEPTUNE 2 ROVER ULTRA DURING A PROCEDURE, FLUID STARTED TO BACKFLOW DOWN ONE OF THE SUCTION TUBES THAT WAS CONNECTED TO THE "BEAN BAG". THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THERE WAS NO MEDICAL TREATMENT OR INTERVENTION REQUIRED AS A RESULT OF THE EVENT AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322092 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1