BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2123326 · Received June 8, 2011

    Report

    Report Number
    1811755-2011-02062
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE REP AND THE EVENT WAS CONFIRMED. THE WATER SUPPLIED BY THE DOCKER WAS 185 TO 190 DEGREES FAHRENHEIT AND THE O-RING UNDER THE FLAPPER VALVE COULD NOT WITHSTAND THE HEAT AND ALLOWED THE WATER TO PASS DURING THE WASH CYCLE. ACCORDING TO THE NEPTUNE WASTE MANAGEMENT SYSTEM INSTRUCTIONS FOR USE THE WATER TEMPERATURE SHOULD BE 40 TO 110 DEGREES FAHRENHEIT. THE REPAIR TECHNICIAN NOTIFIED THE CUSTOMER TO ENSURE THAT THE COLD WATER WAS NOT TURNED OFF. THE DEVICE WAS REPAIRED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLAPPER VALVE ON THE NEPTUNE KEEPS OPENING DURING DOCKING AND SPITTING OUT FLUID. THERE WAS NO PT INVOLVEMENT AND NO ADVERSE CONSEQUENCES RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK