BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 5038217 · Received August 28, 2015

    Report

    Report Number
    0001811755-2015-03143
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    August 5, 2015
    Report Date
    August 5, 2015
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    PMA / PMN Number
    K132671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP PRIOR TO A SURGICAL PROCEDURE AT THE USER FACILITY THE DEVICE BEGAN SMOKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571376 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1