BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAC AND POWER POLE

    MDR report key: 2003867 · Received February 7, 2011

    Report

    Report Number
    1811755-2011-00363
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    August 4, 2010
    Report Date
    August 4, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SVC TECH INSPECTED THE UNIT AND FOUND A HUBBLE LOCK STYLE END ON THE PLUG. HE INSPECTED THE INSIDE OF THE PLUG AND FOUND THAT THE ENDS OF IT WERE BURNT. THE POWER PLUG WAS REPLACED, THE UNIT PASSED ALL REQUIRED TESTS, AND IT WAS PUT BACK INTO SVC.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE POWER CORD DID NOT HAVE POWER. THE FIELD SVC TECH FOUND THE INSIDE OF THE PLUG WAS BURNT. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    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