BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 3092134 · Received May 3, 2013

    Report

    Report Number
    0001811755-2013-01007
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN REPLACED THE PLUG ON THE END OF THE POWER CORD, TESTED THE UNIT AND RETURNED THE UNIT TO SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE POWER CORD ON THE NEPTUNE ROVER WAS SPARKING WHEN THE UNIT WAS BEING DOCKED. THERE WAS NO PATIENT INVOLVEMENT AND NO USER OR PATIENT INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194200 NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE APPARATUS, EXHAUST, SURGICAL FYD STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1