BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 3 ROVER (120V)

    MDR report key: 6200247 · Received December 22, 2016

    Report

    Report Number
    0001811755-2016-02905
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    November 29, 2016
    Report Date
    December 22, 2016
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    PMA / PMN Number
    K153407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SPARKED WHEN IT WAS PLUGGED IN. THIS EVENT OCCURRED DURING NORMAL USE. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850014 NEPTUNE 3 ROVER (120V) APPARATUS, EXHAUST, SURGICAL JCX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1