BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE

    MDR report key: 2042840 · Received March 30, 2011

    Report

    Report Number
    1811755-2011-01013
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER CORD WAS REPLACED ON THE DEVICE. THE DEVICE THEN MET ALL SPECIFICATION AND WAS PUT BACK INTO SERVICE. OVER EXTENDED YEARS OF USE THE POWER PLUG WIRES CAN DETACH OR BECOME LOOSENED FROM THE POWER PLUG CAUSING LOSS OF SYSTEM FUNCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRONGS ON THE POWER PLUG WERE LOOSE, CAUSING ARCING AND PRODUCING HEAT. THIS WAS DISCOVERED DURING A SERVICE REPAIR. THERE WAS NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE ROVER WITHOUT SMOKE EVAC AND POWER POLE AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING ROOM FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK