BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE ROVER WITH SMOKE EVAL AND POWER POLE

    MDR report key: 2482282 · Received March 2, 2012

    Report

    Report Number
    1811755-2012-00731
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE TECH WILL BE DISPATCHED TO EVALUATE THE ROVER, ONCE THE USER FACILITY AUTHORIZES A SERVICE VISIT. A F/U REPORT WILL BE SUBMITTED IF THE PRODUCT IS EVALUATED, OR IF ANY ADDITIONAL EVENT DETAILS ARE RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROVER BEGAN SMOKING. NO FURTHER INFO WAS PROVIDED BY THE USER FACILITY. ATTEMPTS TO OBTAIN ADDITIONAL INFO WERE UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK