BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEPTUNE 2 DOCKING STATION (120V)

    MDR report key: 2896529 · Received November 20, 2012

    Report

    Report Number
    1811755-2012-04123
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 19, 2012
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    FYD
    PMA / PMN Number
    K012991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MFR FIELD SERVICE TECH WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE DEVICE. VISUAL INSPECTION REVEALED BURN MARKS ON THE POWER CORD CONNECTOR. THE SERVICE TECH DETERMINED THAT WATER FROM A FLOOR UTILITY SINK CONTACTED THE POWER MODULE THAT THE POWER CORD CONNECTS WITH, CAUSING AN ELECTRICAL SHORTAGE AND THERMAL DAMAGE TO THE CORD CONNECTOR. THE POWER CORD AND POWER MODULE WERE REPLACED, AND THE DOCKING STATION WAS RETURNED TO USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EVAL CONDUCTED BY A MFR FIELD SERVICE TECH, THERMAL DAMAGE WAS DISCOVERED ON THE DOCKING STATION POWER CORD CONNECTOR. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, SO THERE WAS NO PT INVOLVEMENT. NO USER INJURY WAS REPORTED AND NO OTHER ADVERSE CONSEQUENCES WERE ALLEGED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE 2 DOCKING STATION (120V) FYD STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK