BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 1930496 · Received November 30, 2010

    Report

    Report Number
    1811755-2010-01836
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE REP AND THE COMPLAINT COULD NOT BE CONFIRMED. IN AN ATTEMPT TO RECREATE THE ISSUES OF MULTIPLE ERRORS WHILE DOCKING, THE SMALL AND LARGE CANISTERS WERE FILLED WITH WATER BY USING VACUUM SUCTION. THE ROVER WAS DOCKED THREE TIMES WITHOUT ANY ISSUES. NO ISSUES WERE FOUND AND UNIT WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER IS NOT DOCKING AND HAS MULTIPLE ERRORS WHILE DOCKING. THIS CAUSED A DELAY IN A CASE FOR UP TO 35 MINUTES. THERE WAS NO ADD'L MEDICAL TREATMENT REQUIRED OR ADVERSE CONSEQUENCES. THE ACCOUNT USED A BACK UP ROVER TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE 2 ROVER ULTRA (120V) AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK