BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 2496665 · Received March 15, 2012

    Report

    Report Number
    1811755-2012-00961
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    December 22, 2011
    Report Date
    December 22, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MANUFACTURER FIELD SERVICE TECHNICIAN WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE. VISUAL INSPECTION REVEALED A CRACKED CONNECTOR ON THE FLUID INLET TUBING AND BENT WASHERS ON THE COUPLING CLIP. THE DAMAGED COMPONENTS WERE REPLACED AND THE UNIT WAS RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PREPARING THE ROVER FOR FIRST USE, NUMEROUS GALLONS OF FRESH WATER WERE BEING PUMPED INTO THE UNIT WHICH SUBSEQUENTLY LEAKED OUT AND FLOODED THE ROOM. NO PERMANENT FACILITY DAMAGE WAS REPORTED. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED, AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE 2 ROVER ULTRA (120V) FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK