BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 1975672 · Received January 5, 2011

    Report

    Report Number
    1811755-2011-00005
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    August 2, 2010
    Report Date
    August 2, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE TECHNICIAN. THE POWER PLUG WAS REPLACED AND PASSED ALL SAFETY CHECKS. THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE MANUFACTURER'S FIELD SERVICE REPRESENTATIVE WAS SERVICING A ROVER, THE POWER PLUG ON THE NEPTUNE WAS ARCING WHEN IT WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK