BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 3757921 · Received April 17, 2014

    Report

    Report Number
    0001811755-2014-01380
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 21, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    PMA / PMN Number
    K132671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED EVENT. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE AC POWER BOARD. A FAILURE OF AN ELECTRICAL COMPONENT CAN RESULT IN SPARKING AND A BURNING ODOR. THE TECHNICIAN REPLACED THE AC POWER BOARD AND THE ROVER FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS IS ONGOING; ADDITIONAL INFORMATION MAY BE SUBMITTED ONCE THE RESULTS ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE 2 ROVER ULTRA WAS SPARKING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE 2 ROVER ULTRA WAS SPARKING AT THE USER FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234986 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1