BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPAIR NEPTUNE ROVER

    MDR report key: 2000586 · Received February 1, 2011

    Report

    Report Number
    1811755-2011-00282
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY A FIELD SERVICE REPRESENTATIVE. THE INVESTIGATION IS ONGOING. THIS REPORTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER IS SMOKING AND HAS A BURNING SMELL DURING A PROCEDURE. THE DEVICE WAS REMOVED FROM THE ROOM AND ANOTHER WAS BROUGHT IN TO COMPLETE THE PROCEDURE. THERE WERE NO DELAYS AND NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPAIR NEPTUNE ROVER AIR-HANDLING APPARATUS FOR A SURGICAL OPERATING RO FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK