BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 ROVER ULTRA (120V)

    MDR report key: 3790606 · Received May 5, 2014

    Report

    Report Number
    0001811755-2014-01612
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    STRYKER INSTRUMENTS-KALAMAZOO
    Product Code
    JCX
    PMA / PMN Number
    K132671
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN WAS ABLE TO CONFIRM THE REPORTED EVENT. HE FOUND THAT THE POWER CORD HAD EXPOSED WIRES. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO THE POWER CORD. THE POWER CORD¿S INSULATION CAN BREAK DOWN EXPOSING THE BARE COPPER WIRES DUE TO BEING EXPOSED TO ROUGH SURFACES, SHARP EDGES, OR CORNERS. THE DEVICE WAS REPAIRED AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEPTUNE 2 ROVER ULTRA (120V) HAD BARE WIRES SHOWING THROUGH THE INSULATION OF THE POWER CORD DURING REPAIR BY A STRYKER FIELD SERVICE TECHNICIAN. 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 (120V) HAD BARE WIRES SHOWING THROUGH THE INSULATION OF THE POWER CORD DURING REPAIR BY A STRYKER FIELD SERVICE TECHNICIAN. THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE CONSEQUENCES ASSOCIATED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269333 NEPTUNE 2 ROVER ULTRA (120V) APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED JCX STRYKER INSTRUMENTS-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1