BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2003874 · Received February 7, 2011

    Report

    Report Number
    1811755-2011-00362
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC TECH INSTALLED A NEW MOTOR AND HARNESS. THE UNIT PASSED ALL TESTS AND WAS RETURNED TO SVC.

    Description of Event or Problem · 1

    IT WAS DISCOVERED DURING THE REPAIR PROCESS THAT THE WIRING HARNESS WAS BURNED AND MELTED. THERE WAS NO ALLEGATION OF SMOKE OR FIRE REPORTED AND THERE WERE NO ADVERSE CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK